Oral Tissue Tolerance of a Mouthrinse

Assessment of the Oral Tissue Tolerance of a Potassium Oxalate Containing Mouthrinse

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01009554

Enrollment

Registered

2009-11-06

Start date

2009-10-31

Completion date

2009-12-31

Last updated

2015-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Health

Keywords

Mouthwashes

Brief summary

This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. The dentist will look at the mouth to make sure the mouthwash does not irritate the mouth. The dentist will also look at the color of the teeth and amount of stain on the front teeth.

Detailed description

This is an 8-week, randomized, observer-blind, controlled, parallel group clinical study design to assess the oral tissue tolerance of a potassium oxalate containing mouthrinse. Subjects will have their oral soft/hard tissues assessed and will be evaluated for stain levels and tooth color shades at Screening/Baseline (Visit 1), Week 4 (Visit 2), Week 6 (Visit 3) and Week 8 (Visit 4). Subjects will be instructed to brush their teeth two times daily in their usual manner using the provided sodium fluoride toothpaste. Subjects assigned to the mouthrinse group will be instructed to rinse twice daily after brushing.

Interventions

DEVICEPotassium Oxylate Mouthwash

Rinse with 10 mL for 60 seconds, twice daily after brushing in usual manner with a sodium fluoride dentifrice

DRUGSodium Fluoride Dentifrice

Brush in usual manner, twice daily, with a sodium fluoride dentifrice

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Males and females at least 18 years of age and in good general and oral health. * Volunteers must read, sign, and receive a signed copy of the Informed Consent Form after the nature of the study has been fully explained. * Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the study. * Willingness to refrain from using any breath freshener products or unassigned oral care products (i.e., oral care strips, candy-type mints, sprays, chewing gums, throat lozenges, cough drops, mouthwashes or teeth whitening products) throughout the duration of the study. * Willingness to refrain from using any whitening products and smokeless tobacco products within one week prior to and for the duration of the study, in order to reduce alternate sources of potential irritation. * A minimum of 16 natural teeth, including at least 10 of the 12 anterior teeth (#6-11, #22-27, however, #7-10 must be present), with scorable facial and lingual surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count. * Classic Vita® Shade minimum value of A2 or darker on at least 2 of the 4 maxillary anterior teeth (#7-10). * Absence of abnormal or severely fissured tongue, geographic tongue, tongue piercing or any obvious tongue abnormalities that may interfere with the assessment of oral irritation. * Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect). * Absence of neglected dental health (i.e. gross calculus deposits or rampant caries based on visual examination), significant oral soft tissue pathology, systemically-related gingival enlargement, tissue damage due to ill-fitting appliances or restoration, or extreme crowding or overlapping of teeth

Exclusion criteria

* Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.). * History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. * History or current evidence of significant oral soft tissue pathology, excluding gingivitis, based on the dentist's visual examination and at the discretion of the investigator. * Prior participation in any oral hygiene or product clinical study within the previous 30 days. * Therapy with any medications, currently or within the last 30 days, which might interfere with the outcome of the study by affecting tooth color or stain formation (i.e., certain antimicrobial mouthrinses and antibiotics, such as chlorhexidine). * Restorations on 10% or more of the facial surfaces of the maxillary anterior incisor teeth. * Dental fluorosis, hypoplasia, restorations, tetracycline stains, or other enamel surface irregularities that may interfere with evaluation of the selected teeth. * Visual evidence of Moderate/advanced periodontitis (ADA Type III, IV). Orthodontic bands, appliances, bridges, numerous crowns, removable orthodontic appliances or partial dentures. * Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results). * Regular use of whitening products within 1 week prior to Screening/Baseline. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for the entry into this trial.

Design outcomes

Primary

Measure	Time frame	Description
Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment	8 weeks	The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L\, a\, and b\* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = \[(ΔL\)\^2 + (Δa\)\^2 + (Δb\*)\^2\]\^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
Oral Tissue Tolerance	through 8 weeks	Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.

Secondary

Measure	Time frame	Description
Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment	4 weeks	The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L\* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.
Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment	6 weeks	The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L\* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.
Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment	8 weeks	The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L\* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.
Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment	4 weeks	The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b\* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.
Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment	6 weeks	The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b\* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.
Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment	8 weeks	The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b\* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.
Mean Stain Score Over All Tooth Sites at 4 Weeks	4 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score Over All Tooth Sites at 6 Weeks	6 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score Over All Tooth Sites at 8 Weeks	8 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Intensity Over All Tooth Sites at 4 Weeks	4 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity Over All Tooth Sites at 6 Weeks	6 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity Over All Tooth Sites at 8 Weeks	8 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Area Over All Tooth Sites at 4 Weeks	4 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Area Over All Tooth Sites at 6 Weeks	6 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Area Over All Tooth Sites at 8 Weeks	8 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks	4 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks	6 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks	8 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks	4 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks	6 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks	8 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks	4 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks	6 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks	8 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Mean Stain Score for Gingival Sites at 4 Weeks	4 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score for Gingival Sites at 6 Weeks	6 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score for Gingival Sites at 8 Weeks	8 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Intensity for Gingival Sites at 4 Weeks	4 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity for Gingival Sites at 6 Weeks	6 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity for Gingival Sites at 8 Weeks	8 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Area for Gingival Sites at 4 Weeks	4 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Mean Stain Area for Gingival Sites at 6 Weeks	6 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Mean Stain Area for Gingival Sites at 8 Weeks	8 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Mean Stain Score for Body Sites at 4 Weeks	4 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score for Body Sites at 6 Weeks	6 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score for Body Sites at 8 Weeks	8 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Intensity for Body Sites at 4 Weeks	4 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity for Body Sites at 6 Weeks	6 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity for Body Sites at 8 Weeks	8 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Area for Body Sites at 4 Weeks	4 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Area for Body Sites at 6 Weeks	6 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Area for Body Sites at 8 Weeks	8 weeks	The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Score for Facial Sites at 4 Weeks	4 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score for Facial Sites at 6 Weeks	6 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score for Facial Sites at 8 Weeks	8 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Intensity for Facial Sites at 4 Weeks	4 weeks	The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity for Facial Sites at 6 Weeks	6 weeks	The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity for Facial Sites at 8 Weeks	8 weeks	The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Area for Facial Sites at 4 Weeks	4 weeks	The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Area for Facial Sites at 6 Weeks	6 weeks	The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Area for Facial Sites at 8 Weeks	8 weeks	The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Score for Lingual Sites at 4 Weeks	4 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Mean Stain Score for Lingual Sites at 6 Weeks	6 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment	4 weeks	The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L\, a\, and b\* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = \[(ΔL\)\^2 + (Δa\)\^2 + (Δb\*)\^2\]\^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
Mean Stain Intensity for Lingual Sites at 4 Weeks	4 weeks	The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity for Lingual Sites at 6 Weeks	6 weeks	The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Intensity for Lingual Sites at 8 Weeks	8 weeks	The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Mean Stain Area for Lingual Sites at 4 Weeks	4 weeks	The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Area for Lingual Sites at 6 Weeks	6 weeks	The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Area for Lingual Sites at 8 Weeks	8 weeks	The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Mean Stain Score for Lingual Sites at 8 Weeks	8 weeks	The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment	6 weeks	The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L\, a\, and b\* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = \[(ΔL\)\^2 + (Δa\)\^2 + (Δb\*)\^2\]\^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Crest® Regular Toothpaste Crest® Cavity Protection Regular Toothpaste (Brushing Only)	48
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)	48
Total	96

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	1
Overall Study	Noncompliant with Study Product	0	3
Overall Study	Withdrawal by Subject	1	3

Baseline characteristics

Characteristic	Crest® Regular Toothpaste	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Total
Age, Continuous	47.6 years STANDARD_DEVIATION 9.96	49.8 years STANDARD_DEVIATION 8.08	48.7 years STANDARD_DEVIATION 9.08
Region of Enrollment USA	48 participants	48 participants	96 participants
Sex: Female, Male Female	40 Participants	40 Participants	80 Participants
Sex: Female, Male Male	8 Participants	8 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	3 / 48	2 / 48
serious Total, serious adverse events	0 / 48	0 / 48

Outcome results

Primary

Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L\*, a\*, and b\* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = \[(ΔL\*)\^2 + (Δa\*)\^2 + (Δb\*)\^2\]\^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.

Time frame: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment	0.909 units on a scale	Standard Error 0.0612
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment	1.035 units on a scale	Standard Error 0.065

Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.16895% CI: [-0.054, 0.306]ANCOVA

Primary

Oral Tissue Tolerance

Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.

Time frame: through 8 weeks

Population: Analysis was based on the Safety Analysis Set, defined as all participants who used at least one dose of investigational product.

Arm	Measure	Group	Value (NUMBER)
Crest® Regular Toothpaste	Oral Tissue Tolerance	Participants with ≥ one treatment-related AE	2.1 percentage of participants
Crest® Regular Toothpaste	Oral Tissue Tolerance	Sensitivity of teeth	2.1 percentage of participants
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Oral Tissue Tolerance	Participants with ≥ one treatment-related AE	0.0 percentage of participants
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Oral Tissue Tolerance	Sensitivity of teeth	0.0 percentage of participants

Secondary

Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment	0.077 units on a scale	Standard Error 0.0518
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment	-0.117 units on a scale	Standard Error 0.0529

Secondary

Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment	0.123 units on a scale	Standard Error 0.0487
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment	-0.212 units on a scale	Standard Error 0.0498

Secondary

Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment	0.107 units on a scale	Standard Error 0.0639
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment	-0.107 units on a scale	Standard Error 0.0677

Secondary

Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment	0.875 units on a scale	Standard Error 0.0464
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment	0.882 units on a scale	Standard Error 0.0475

Secondary

Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment	0.805 units on a scale	Standard Error 0.0496
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment	1.040 units on a scale	Standard Error 0.0507

Secondary

Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment	0.013 units on a scale	Standard Error 0.0857
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment	0.054 units on a scale	Standard Error 0.0876

Secondary

Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment	0.071 units on a scale	Standard Error 0.0959
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment	-0.090 units on a scale	Standard Error 0.0981

Secondary

Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment	0.158 units on a scale	Standard Error 0.0949
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment	-0.043 units on a scale	Standard Error 0.1006

Secondary

Mean Stain Area for Body Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Body Sites at 4 Weeks	0.064 units on a scale	Standard Error 0.0133
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Body Sites at 4 Weeks	0.056 units on a scale	Standard Error 0.0145

Secondary

Mean Stain Area for Body Sites at 6 Weeks

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Body Sites at 6 Weeks	0.076 units on a scale	Standard Error 0.0158
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Body Sites at 6 Weeks	0.100 units on a scale	Standard Error 0.0169

Secondary

Mean Stain Area for Body Sites at 8 Weeks

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Body Sites at 8 Weeks	0.067 units on a scale	Standard Error 0.018
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Body Sites at 8 Weeks	0.124 units on a scale	Standard Error 0.02

Secondary

Mean Stain Area for Facial Sites at 4 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Facial Sites at 4 Weeks	0.032 units on a scale	Standard Error 0.0147
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Facial Sites at 4 Weeks	0.033 units on a scale	Standard Error 0.016

Secondary

Mean Stain Area for Facial Sites at 6 Weeks

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Facial Sites at 6 Weeks	0.059 units on a scale	Standard Error 0.0188
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Facial Sites at 6 Weeks	0.075 units on a scale	Standard Error 0.0201

Secondary

Mean Stain Area for Facial Sites at 8 Weeks

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Facial Sites at 8 Weeks	0.047 units on a scale	Standard Error 0.0281
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Facial Sites at 8 Weeks	0.160 units on a scale	Standard Error 0.0313

Secondary

Mean Stain Area for Gingival Sites at 4 Weeks

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Gingival Sites at 4 Weeks	0.186 units on a scale	Standard Error 0.0292
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Gingival Sites at 4 Weeks	0.263 units on a scale	Standard Error 0.0319

Secondary

Mean Stain Area for Gingival Sites at 6 Weeks

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Gingival Sites at 6 Weeks	0.184 units on a scale	Standard Error 0.0335
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Gingival Sites at 6 Weeks	0.352 units on a scale	Standard Error 0.0359

Secondary

Mean Stain Area for Gingival Sites at 8 Weeks

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Gingival Sites at 8 Weeks	0.250 units on a scale	Standard Error 0.043
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Gingival Sites at 8 Weeks	0.444 units on a scale	Standard Error 0.0481

Secondary

Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks	0.202 units on a scale	Standard Error 0.0284
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks	0.236 units on a scale	Standard Error 0.0309

Secondary

Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks	0.206 units on a scale	Standard Error 0.0348
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks	0.383 units on a scale	Standard Error 0.0373

Secondary

Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks	0.218 units on a scale	Standard Error 0.0433
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks	0.483 units on a scale	Standard Error 0.0483

Secondary

Mean Stain Area for Lingual Sites at 4 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Lingual Sites at 4 Weeks	0.293 units on a scale	Standard Error 0.0409
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Lingual Sites at 4 Weeks	0.359 units on a scale	Standard Error 0.0448

Secondary

Mean Stain Area for Lingual Sites at 6 Weeks

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Lingual Sites at 6 Weeks	0.277 units on a scale	Standard Error 0.046
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Lingual Sites at 6 Weeks	0.533 units on a scale	Standard Error 0.0495

Secondary

Mean Stain Area for Lingual Sites at 8 Weeks

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area for Lingual Sites at 8 Weeks	0.325 units on a scale	Standard Error 0.056
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area for Lingual Sites at 8 Weeks	0.598 units on a scale	Standard Error 0.0628

Secondary

Mean Stain Area Over All Tooth Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area Over All Tooth Sites at 4 Weeks	0.162 units on a scale	Standard Error 0.0225
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area Over All Tooth Sites at 4 Weeks	0.196 units on a scale	Standard Error 0.0245

Secondary

Mean Stain Area Over All Tooth Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area Over All Tooth Sites at 6 Weeks	0.166 units on a scale	Standard Error 0.027
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area Over All Tooth Sites at 6 Weeks	0.303 units on a scale	Standard Error 0.029

Secondary

Mean Stain Area Over All Tooth Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Area Over All Tooth Sites at 8 Weeks	0.188 units on a scale	Standard Error 0.034
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Area Over All Tooth Sites at 8 Weeks	0.383 units on a scale	Standard Error 0.0379

Secondary

Mean Stain Intensity for Body Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Body Sites at 4 Weeks	0.058 units on a scale	Standard Error 0.0121
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Body Sites at 4 Weeks	0.045 units on a scale	Standard Error 0.0132

Secondary

Mean Stain Intensity for Body Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Body Sites at 6 Weeks	0.075 units on a scale	Standard Error 0.016
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Body Sites at 6 Weeks	0.100 units on a scale	Standard Error 0.0171

Secondary

Mean Stain Intensity for Body Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Body Sites at 8 Weeks	0.063 units on a scale	Standard Error 0.0166
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Body Sites at 8 Weeks	0.112 units on a scale	Standard Error 0.0184

Secondary

Mean Stain Intensity for Facial Sites at 4 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Facial Sites at 4 Weeks	0.027 units on a scale	Standard Error 0.0153
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Facial Sites at 4 Weeks	0.025 units on a scale	Standard Error 0.0167

Secondary

Mean Stain Intensity for Facial Sites at 6 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Facial Sites at 6 Weeks	0.054 units on a scale	Standard Error 0.0192
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Facial Sites at 6 Weeks	0.065 units on a scale	Standard Error 0.0206

Secondary

Mean Stain Intensity for Facial Sites at 8 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Facial Sites at 8 Weeks	0.042 units on a scale	Standard Error 0.0257
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Facial Sites at 8 Weeks	0.144 units on a scale	Standard Error 0.0286

Secondary

Mean Stain Intensity for Gingival Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Gingival Sites at 4 Weeks	0.180 units on a scale	Standard Error 0.0292
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Gingival Sites at 4 Weeks	0.252 units on a scale	Standard Error 0.0318

Secondary

Mean Stain Intensity for Gingival Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Gingival Sites at 6 Weeks	0.180 units on a scale	Standard Error 0.035
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Gingival Sites at 6 Weeks	0.358 units on a scale	Standard Error 0.0375

Secondary

Mean Stain Intensity for Gingival Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Gingival Sites at 8 Weeks	0.241 units on a scale	Standard Error 0.0434
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Gingival Sites at 8 Weeks	0.438 units on a scale	Standard Error 0.0485

Secondary

Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks	0.192 units on a scale	Standard Error 0.0284
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks	0.224 units on a scale	Standard Error 0.0309

Secondary

Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks	0.205 units on a scale	Standard Error 0.035
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks	0.379 units on a scale	Standard Error 0.0374

Secondary

Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks	0.210 units on a scale	Standard Error 0.0422
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks	0.475 units on a scale	Standard Error 0.047

Secondary

Mean Stain Intensity for Lingual Sites at 4 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Lingual Sites at 4 Weeks	0.282 units on a scale	Standard Error 0.0406
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Lingual Sites at 4 Weeks	0.344 units on a scale	Standard Error 0.0444

Secondary

Mean Stain Intensity for Lingual Sites at 6 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Lingual Sites at 6 Weeks	0.279 units on a scale	Standard Error 0.0467
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Lingual Sites at 6 Weeks	0.541 units on a scale	Standard Error 0.0501

Secondary

Mean Stain Intensity for Lingual Sites at 8 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity for Lingual Sites at 8 Weeks	0.314 units on a scale	Standard Error 0.0549
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity for Lingual Sites at 8 Weeks	0.596 units on a scale	Standard Error 0.0614

Secondary

Mean Stain Intensity Over All Tooth Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity Over All Tooth Sites at 4 Weeks	0.154 units on a scale	Standard Error 0.0224
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity Over All Tooth Sites at 4 Weeks	0.184 units on a scale	Standard Error 0.0243

Secondary

Mean Stain Intensity Over All Tooth Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity Over All Tooth Sites at 6 Weeks	0.164 units on a scale	Standard Error 0.0274
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity Over All Tooth Sites at 6 Weeks	0.302 units on a scale	Standard Error 0.0293

Secondary

Mean Stain Intensity Over All Tooth Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Intensity Over All Tooth Sites at 8 Weeks	0.181 units on a scale	Standard Error 0.0334
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Intensity Over All Tooth Sites at 8 Weeks	0.375 units on a scale	Standard Error 0.0372

Secondary

Mean Stain Score for Body Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Body Sites at 4 Weeks	0.132 units on a scale	Standard Error 0.0258
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Body Sites at 4 Weeks	0.112 units on a scale	Standard Error 0.0281

Secondary

Mean Stain Score for Body Sites at 6 Weeks

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Body Sites at 6 Weeks	0.160 units on a scale	Standard Error 0.0337
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Body Sites at 6 Weeks	0.215 units on a scale	Standard Error 0.0361

Secondary

Mean Stain Score for Body Sites at 8 Weeks

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Body Sites at 8 Weeks	0.143 units on a scale	Standard Error 0.0371
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Body Sites at 8 Weeks	0.258 units on a scale	Standard Error 0.0412

Secondary

Mean Stain Score for Facial Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Facial Sites at 4 Weeks	0.063 units on a scale	Standard Error 0.0314
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Facial Sites at 4 Weeks	0.058 units on a scale	Standard Error 0.0342

Secondary

Mean Stain Score for Facial Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Facial Sites at 6 Weeks	0.118 units on a scale	Standard Error 0.0399
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Facial Sites at 6 Weeks	0.140 units on a scale	Standard Error 0.0427

Secondary

Mean Stain Score for Facial Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Facial Sites at 8 Weeks	0.097 units on a scale	Standard Error 0.0576
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Facial Sites at 8 Weeks	0.319 units on a scale	Standard Error 0.0642

Secondary

Mean Stain Score for Gingival Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Gingival Sites at 4 Weeks	0.383 units on a scale	Standard Error 0.0596
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Gingival Sites at 4 Weeks	0.521 units on a scale	Standard Error 0.0652

Secondary

Mean Stain Score for Gingival Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Gingival Sites at 6 Weeks	0.395 units on a scale	Standard Error 0.0732
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Gingival Sites at 6 Weeks	0.732 units on a scale	Standard Error 0.0786

Secondary

Mean Stain Score for Gingival Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Gingival Sites at 8 Weeks	0.526 units on a scale	Standard Error 0.0914
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Gingival Sites at 8 Weeks	0.920 units on a scale	Standard Error 0.1023

Secondary

Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks	0.408 units on a scale	Standard Error 0.059
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks	0.463 units on a scale	Standard Error 0.0643

Secondary

Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks	0.427 units on a scale	Standard Error 0.0712
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks	0.776 units on a scale	Standard Error 0.0762

Secondary

Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks	0.451 units on a scale	Standard Error 0.0889
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks	0.994 units on a scale	Standard Error 0.0991

Secondary

Mean Stain Score for Lingual Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Lingual Sites at 4 Weeks	0.596 units on a scale	Standard Error 0.0831
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Lingual Sites at 4 Weeks	0.716 units on a scale	Standard Error 0.091

Secondary

Mean Stain Score for Lingual Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Lingual Sites at 6 Weeks	0.586 units on a scale	Standard Error 0.0949
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Lingual Sites at 6 Weeks	1.106 units on a scale	Standard Error 0.102

Secondary

Mean Stain Score for Lingual Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score for Lingual Sites at 8 Weeks	0.677 units on a scale	Standard Error 0.1146
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score for Lingual Sites at 8 Weeks	1.244 units on a scale	Standard Error 0.1283

Secondary

Mean Stain Score Over All Tooth Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 4 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score Over All Tooth Sites at 4 Weeks	0.329 units on a scale	Standard Error 0.0464
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score Over All Tooth Sites at 4 Weeks	0.386 units on a scale	Standard Error 0.0505

Secondary

Mean Stain Score Over All Tooth Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 6 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score Over All Tooth Sites at 6 Weeks	0.349 units on a scale	Standard Error 0.0565
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score Over All Tooth Sites at 6 Weeks	0.621 units on a scale	Standard Error 0.0605

Secondary

Mean Stain Score Over All Tooth Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Time frame: 8 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Crest® Regular Toothpaste	Mean Stain Score Over All Tooth Sites at 8 Weeks	0.394 units on a scale	Standard Error 0.0703
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)	Mean Stain Score Over All Tooth Sites at 8 Weeks	0.791 units on a scale	Standard Error 0.0785

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Oral Tissue Tolerance of a Mouthrinse

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment

Oral Tissue Tolerance

Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment

Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment

Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment

Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment

Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment

Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment

Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment

Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment

Mean Stain Area for Body Sites at 4 Weeks

Mean Stain Area for Body Sites at 6 Weeks

Mean Stain Area for Body Sites at 8 Weeks

Mean Stain Area for Facial Sites at 4 Weeks

Mean Stain Area for Facial Sites at 6 Weeks

Mean Stain Area for Facial Sites at 8 Weeks

Mean Stain Area for Gingival Sites at 4 Weeks

Mean Stain Area for Gingival Sites at 6 Weeks

Mean Stain Area for Gingival Sites at 8 Weeks

Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks

Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks

Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks

Mean Stain Area for Lingual Sites at 4 Weeks

Mean Stain Area for Lingual Sites at 6 Weeks

Mean Stain Area for Lingual Sites at 8 Weeks

Mean Stain Area Over All Tooth Sites at 4 Weeks

Mean Stain Area Over All Tooth Sites at 6 Weeks

Mean Stain Area Over All Tooth Sites at 8 Weeks

Mean Stain Intensity for Body Sites at 4 Weeks

Mean Stain Intensity for Body Sites at 6 Weeks

Mean Stain Intensity for Body Sites at 8 Weeks

Mean Stain Intensity for Facial Sites at 4 Weeks

Mean Stain Intensity for Facial Sites at 6 Weeks

Mean Stain Intensity for Facial Sites at 8 Weeks

Mean Stain Intensity for Gingival Sites at 4 Weeks

Mean Stain Intensity for Gingival Sites at 6 Weeks

Mean Stain Intensity for Gingival Sites at 8 Weeks

Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks

Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks

Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks

Mean Stain Intensity for Lingual Sites at 4 Weeks

Mean Stain Intensity for Lingual Sites at 6 Weeks

Mean Stain Intensity for Lingual Sites at 8 Weeks

Mean Stain Intensity Over All Tooth Sites at 4 Weeks

Mean Stain Intensity Over All Tooth Sites at 6 Weeks

Mean Stain Intensity Over All Tooth Sites at 8 Weeks

Mean Stain Score for Body Sites at 4 Weeks

Mean Stain Score for Body Sites at 6 Weeks

Mean Stain Score for Body Sites at 8 Weeks

Mean Stain Score for Facial Sites at 4 Weeks

Mean Stain Score for Facial Sites at 6 Weeks

Mean Stain Score for Facial Sites at 8 Weeks

Mean Stain Score for Gingival Sites at 4 Weeks

Mean Stain Score for Gingival Sites at 6 Weeks

Mean Stain Score for Gingival Sites at 8 Weeks

Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks

Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks

Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks