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A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity

A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03965039
Enrollment
120
Registered
2019-05-28
Start date
2019-07-08
Completion date
2019-10-03
Last updated
2020-10-30

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

Conditions

Dentin Hypersensitivity

Brief summary

The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period.

Interventions

DEVICEDipotassium oxalate toothpaste

Experimental dipotassium oxalate (3%) toothpaste

Marketed stannous fluoride (0.454%) toothpaste

Marketed potassium nitrate (5%) toothpaste

Marketed sodium monofluorophosphate (0.76%) toothpaste

Sponsors

Procter and Gamble
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * sign a Confidentiality Disclosure Agreement (CDA); * be in good general health as determined by the Investigator/designee; * agree not to participate in any other oral/dental product studies during the course of this study; * agree to delay any dentistry (including dental prophylaxis) until the study has been completed; * agree to refrain from the use of any non-study oral hygiene products\*; * exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect); * have an absence of extensive calculus above the gum line; * agree to return for all scheduled visits and follow study procedures; and * have two teeth with a Schiff sensitivity score \> 1 in response to air challenge and a Yeaple probe score of 10-20 g in response to tactile challenge. (If these two eligible teeth are located in the same quadrant, they have to be separated by 2 other teeth.)

Exclusion criteria

* having taken anti-inflammatory, analgesic, or psychotropic drugs, chronically; * chronic medical debilitating disease associated with constant or intermittent episodes of daily pain; * any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Baseline visit; * dental prophylaxis within 2 weeks prior to Baseline visit; * having received professional desensitizing treatment or having used over-the-counter desensitizing products within 6 weeks of the Baseline visit; * having periodontal surgery, orthodontic treatment, or teeth restored in the preceding three months; * having teeth or periodontium with pathology or defects likely to cause pain; * having a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics; * self-reported pregnancy or lactation; * having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity; * history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients; * any diseases or condition that might interfere with the safe participation in the study; * inability to undergo study procedures; * having severe xerostomia; * having had active caries within the 12 months; * having high risk for caries development (rampant caries, multiple dental restorations, crowns with compromised margin) per examiners discretion; * teeth will be excluded from study measurements if they: * have deep, defective, or facial restorations; * have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis; * present with tendency for spontaneous bleeding; * have been scaled/root planed or restored within the past 3 months.

Design outcomes

Primary

MeasureTime frameDescription
Air Challenge4 weeksThe Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Secondary

MeasureTime frameDescription
Baseline Air ChallengeBaselineThe Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.
Air Challenge3 daysThe Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
Baseline Yeaple ProbeBaselineTactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form.
Tactile Threshold3 daysTactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

Countries

United States

Participant flow

Participants by arm

ArmCount
Marketed Stannous Fluoride Toothpaste
Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste
30
Marketed Potassium Nitrate Toothpaste
Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste
30
Marketed Sodium Monofluorophosphate Toothpaste
Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste
30
Experimental Dipotassium Oxalate Toothpaste
Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
30
Total120

Baseline characteristics

CharacteristicMarketed Stannous Fluoride ToothpasteMarketed Potassium Nitrate ToothpasteMarketed Sodium Monofluorophosphate ToothpasteExperimental Dipotassium Oxalate ToothpasteTotal
Age, Continuous38.73 years
STANDARD_DEVIATION 11.52
42.53 years
STANDARD_DEVIATION 13.28
39.03 years
STANDARD_DEVIATION 11.04
39.87 years
STANDARD_DEVIATION 10.42
40.04 years
STANDARD_DEVIATION 11.56
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants7 Participants6 Participants7 Participants25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants23 Participants24 Participants23 Participants95 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
5 Participants1 Participants2 Participants1 Participants9 Participants
Race (NIH/OMB)
Black or African American
3 Participants2 Participants7 Participants7 Participants19 Participants
Race (NIH/OMB)
More than one race
1 Participants3 Participants5 Participants7 Participants16 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
20 Participants24 Participants15 Participants15 Participants74 Participants
Sex: Female, Male
Female
22 Participants21 Participants21 Participants22 Participants86 Participants
Sex: Female, Male
Male
8 Participants9 Participants9 Participants8 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 300 / 300 / 30
other
Total, other adverse events
0 / 305 / 300 / 303 / 30
serious
Total, serious adverse events
0 / 300 / 300 / 300 / 30

Outcome results

Primary

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Time frame: 4 weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteAir Challenge1.17 score on a scaleStandard Error 0.141
Marketed Potassium Nitrate ToothpasteAir Challenge1.48 score on a scaleStandard Error 0.087
Marketed Sodium Monofluorophosphate ToothpasteAir Challenge2.26 score on a scaleStandard Error 0.066
Experimental Dipotassium Oxalate ToothpasteAir Challenge1.39 score on a scaleStandard Error 0.116
Secondary

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Time frame: 3 days

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteAir Challenge1.93 score on a scaleStandard Error 0.081
Marketed Potassium Nitrate ToothpasteAir Challenge2.05 score on a scaleStandard Error 0.085
Marketed Sodium Monofluorophosphate ToothpasteAir Challenge2.36 score on a scaleStandard Error 0.062
Experimental Dipotassium Oxalate ToothpasteAir Challenge1.88 score on a scaleStandard Error 0.085
Secondary

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Time frame: 2 weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteAir Challenge1.44 score on a scaleStandard Error 0.117
Marketed Potassium Nitrate ToothpasteAir Challenge1.78 score on a scaleStandard Error 0.092
Marketed Sodium Monofluorophosphate ToothpasteAir Challenge2.24 score on a scaleStandard Error 0.074
Experimental Dipotassium Oxalate ToothpasteAir Challenge1.61 score on a scaleStandard Error 0.103
Secondary

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Time frame: 8 weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteAir Challenge0.96 score on a scaleStandard Error 0.144
Marketed Potassium Nitrate ToothpasteAir Challenge1.24 score on a scaleStandard Error 0.094
Marketed Sodium Monofluorophosphate ToothpasteAir Challenge2.22 score on a scaleStandard Error 0.059
Experimental Dipotassium Oxalate ToothpasteAir Challenge1.18 score on a scaleStandard Error 0.134
Secondary

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluophosphate toothpaste (from week 8 to week 11).

Time frame: 11 weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteAir Challenge1.32 score on a scaleStandard Error 0.147
Marketed Potassium Nitrate ToothpasteAir Challenge1.40 score on a scaleStandard Error 0.121
Marketed Sodium Monofluorophosphate ToothpasteAir Challenge2.18 score on a scaleStandard Error 0.071
Experimental Dipotassium Oxalate ToothpasteAir Challenge1.32 score on a scaleStandard Error 0.145
Secondary

Baseline Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteBaseline Air Challenge2.45 score on a scaleStandard Deviation 0.379
Marketed Potassium Nitrate ToothpasteBaseline Air Challenge2.40 score on a scaleStandard Deviation 0.381
Marketed Sodium Monofluorophosphate ToothpasteBaseline Air Challenge2.52 score on a scaleStandard Deviation 0.382
Experimental Dipotassium Oxalate ToothpasteBaseline Air Challenge2.45 score on a scaleStandard Deviation 0.356
Secondary

Baseline Yeaple Probe

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteBaseline Yeaple Probe10.33 score on a scaleStandard Deviation 1.826
Marketed Potassium Nitrate ToothpasteBaseline Yeaple Probe10.50 score on a scaleStandard Deviation 1.526
Marketed Sodium Monofluorophosphate ToothpasteBaseline Yeaple Probe11.00 score on a scaleStandard Deviation 2.754
Experimental Dipotassium Oxalate ToothpasteBaseline Yeaple Probe10.50 score on a scaleStandard Deviation 2.013
Secondary

Tactile Threshold

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

Time frame: 3 days

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteTactile Threshold16.70 score on a scaleStandard Error 1.039
Marketed Potassium Nitrate ToothpasteTactile Threshold13.74 score on a scaleStandard Error 0.704
Marketed Sodium Monofluorophosphate ToothpasteTactile Threshold12.41 score on a scaleStandard Error 0.741
Experimental Dipotassium Oxalate ToothpasteTactile Threshold15.90 score on a scaleStandard Error 1.24
Secondary

Tactile Threshold

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

Time frame: 2 weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteTactile Threshold22.70 score on a scaleStandard Error 1.987
Marketed Potassium Nitrate ToothpasteTactile Threshold18.57 score on a scaleStandard Error 1.528
Marketed Sodium Monofluorophosphate ToothpasteTactile Threshold14.17 score on a scaleStandard Error 1.022
Experimental Dipotassium Oxalate ToothpasteTactile Threshold21.61 score on a scaleStandard Error 1.533
Secondary

Tactile Threshold

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

Time frame: 4 weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteTactile Threshold26.76 score on a scaleStandard Error 2.548
Marketed Potassium Nitrate ToothpasteTactile Threshold22.76 score on a scaleStandard Error 1.71
Marketed Sodium Monofluorophosphate ToothpasteTactile Threshold13.93 score on a scaleStandard Error 0.988
Experimental Dipotassium Oxalate ToothpasteTactile Threshold25.06 score on a scaleStandard Error 1.556
Secondary

Tactile Threshold

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

Time frame: 8 weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteTactile Threshold29.30 score on a scaleStandard Error 2.728
Marketed Potassium Nitrate ToothpasteTactile Threshold27.45 score on a scaleStandard Error 1.926
Marketed Sodium Monofluorophosphate ToothpasteTactile Threshold13.45 score on a scaleStandard Error 0.824
Experimental Dipotassium Oxalate ToothpasteTactile Threshold28.49 score on a scaleStandard Error 2.044
Secondary

Tactile Threshold

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluorophosphate toothpaste (from week 8 to week 11).

Time frame: 11 weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Marketed Stannous Fluoride ToothpasteTactile Threshold24.75 score on a scaleStandard Error 2.631
Marketed Potassium Nitrate ToothpasteTactile Threshold21.92 score on a scaleStandard Error 1.801
Marketed Sodium Monofluorophosphate ToothpasteTactile Threshold12.71 score on a scaleStandard Error 0.664
Experimental Dipotassium Oxalate ToothpasteTactile Threshold24.85 score on a scaleStandard Error 1.863

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