Dental Plaque, Gingivitis
Conditions
Brief summary
The objective of this clinical research study is to evaluate the efficacy of floss to an essential oil alcohol-containing mouthwash, an essential oil alcohol-free mouthwash, and a CPC+Zn alcohol-free mouthwash in reducing dental plaque and gingivitis.
Interventions
DRUGMouthwash
Antiplaque/Antigingivitis Mouthwash
DEVICEFloss
Dental Floss
DEVICEToothbrush
Soft bristled, manual toothbrush
DRUGToothpaste
Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female volunteers at least 18 years of age and in general good health. * Willing and able to understand and sign the informed consent form. * Whole mouth mean MGI ≥1.95, whole mouth mean TPI≥1.95, and ≥10% bleeding sites * Be willing to conform to the study protocol and procedures. * No sites with probing depth \>4 mm. * Minimum of 20 natural teeth with scorable facial and lingual surfaces
Exclusion criteria
* Medical condition which requires premedication prior to dental visits/procedure. * Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner. * Active disease of the hard oral tissues. * Significant oral soft tissue pathology, excluding plaque-induced gingivitis. * Moderate to severe periodontitis (stages II-IV) per the EFP S3 guidelines. * Subjects with fixed or removable orthodontic appliances or removable partial dentures. * Dental prophylaxis within 30 days prior to study start. * Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start. * Use of chemotherapeutic oral care products within two weeks prior to study start. * Participation in any other clinical study within 30 days prior to enrollment into this study. * Subjects who must receive dental treatment during the study dates. * Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy). * Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse. * Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1) * Pregnant or lactating subjects, or subjects planning to become pregnant during the course of the study. * Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits; * Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interproximal mean Modified Gingival Index (MGI) | 12 weeks | MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Interproximal MGI includes the mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per below. 0 = no inflammation; no redness 1. = mild inflammation; slight changes in color and texture, but not in all portions of gingival marginal or papillary 2. = mild inflammation; slight changes in color and texture in all portions of gingival margin or papillary 3. = moderate inflammation; bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary 4. = severe inflammation; erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interproximal mean Turesky Modification of the Quigley-Hein Plaque Index (TPI) | 1, 4, and 12 weeks | Dental plaque will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as follows: 0=No plaque 1. Separate flecks of plaque at the cervical margin 2. A thin, continuous band of plaque (up to 1 mm) at the cervical margin 3. A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth 4. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth 5. Plaque covering 2/3 or more of the side of the crown of the tooth Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per above. |
| Whole Mouth mean Turesky Modification of the Quigley-Hein Plaque Index (TPI) | 1, 4, and 12 weeks | Dental plaque will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as follows: 0=No plaque 1. Separate flecks of plaque at the cervical margin 2. A thin, continuous band of plaque (up to 1 mm) at the cervical margin 3. A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth 4. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth 5. Plaque covering 2/3 or more of the side of the crown of the tooth Whole Mouth mean includes all six sites. Higher scores indicate a worse outcome, per above. |
| Interproximal mean Expanded Bleeding Index (EBI) | 1, 4, and 12 weeks | EBI will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) by engaging a probe 1 mm into the gingival crevice and applying moderate pressure whilst sweeping from interproximal to interproximal along the sulcular epithelium. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. A higher score indicates a worse outcome, per below. 0 = no bleeding after 30 seconds 1. = bleeding upon probing after 30 seconds 2. = immediate bleeding observed |
| Whole Mouth Expanded Bleeding Index (EBI) | 1, 4, and 12 weeks | EBI will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) by engaging a probe 1 mm into the gingival crevice and applying moderate pressure whilst sweeping from interproximal to interproximal along the sulcular epithelium. Whole Mouth mean includes all six sites. A higher score indicates a worse outcome, per below. 0 = no bleeding after 30 seconds 1. = bleeding upon probing after 30 seconds 2. = immediate bleeding observed |
| Whole Mouth mean Modified Gingival Index (MGI) | 1, 4, and 12 weeks | MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Whole Mouth MGI includes all six sites. Higher scores indicate a worse outcome, per below. 0 = no inflammation; no redness 1. = mild inflammation; slight changes in color and texture, but not in all portions of gingival marginal or papillary 2. = mild inflammation; slight changes in color and texture in all portions of gingival margin or papillary 3. = moderate inflammation; bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary 4. = severe inflammation; erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration |
| Whole Mouth mean Bleeding on Probing (BOP) | 12 weeks | Bleeding on probing will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as 1 = yes bleeding, 0 = no bleeding. Whole Mouth mean includes all six sites. A higher score indicates a worse outcome. |
| Interproximal mean Probing Depth (PD) | 12 weeks | Probing depth will be measured at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) using a calibrated periodontal probe to ensure precision and consistency. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. Measurements will be recorded to the nearest millimeter, with particular attention to maintaining gentle and consistent pressure to avoid measurement variability. Larger measurements indicate a worse condition. |
| Whole Mouth mean Probing Depth (PD) | 12 weeks | Probing depth will be measured at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) using a calibrated periodontal probe to ensure precision and consistency. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. Measurements will be recorded to the nearest millimeter, with particular attention to maintaining gentle and consistent pressure to avoid measurement variability. Larger measurements indicate a worse condition. |
| Interproximal mean Bleeding on Probing (BOP) | 12 weeks | Bleeding on probing will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as 1 = yes bleeding, 0 = no bleeding. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. A higher score indicates a worse outcome. |
Countries
United States
Outcome results
None listed