A 12-Week Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
| Registry | NCT07398846 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 134 (Actual) |
| Sponsor | Colgate Palmolive (Industry) |
| Conditions | Plaque |
| Interventions | 0.454%Stannous fluoride toothpaste, 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe, 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste, 0.022% Sodium Fluoride mouthwash (Drug) |
| Dates | start 2026-01-26, primary completion 2026-04-29, completion 2026-04-29, first posted 2026-02-10, last updated 2026-05-22 |
| Locations | 1 site in United States |
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All trials for Plaque All trials of 0.454%Stannous fluoride toothpaste All trials of 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe
To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test 1 | Experimental | Drug: 0.454%Stannous fluoride toothpaste; Drug: 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe | instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 20mL for 30 secs with mouthwash provided |
| Test 2 | Experimental | Drug: 0.454%Stannous fluoride toothpaste; Drug: 0.022% Sodium Fluoride mouthwash | instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided |
| Test 3 | Active comparator | Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste; Drug: 0.022% Sodium Fluoride mouthwash | instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and manual toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided |
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
Inclusion Criteria: * Signed Informed Consent Form. * Male and female subjects aged 18-70 years, inclusive. * Availability for the twelve-week duration of the clinical research study. * Good general health based on the opinion of the study investigator * Minimum of 20 permanent natural teeth (excluding third molars). * Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. * Initial mean plaque index of at least 0.6 as determined by Rustogi Modification of the Navy plaque index. Exclusion Criteria: * Presence of orthodontic appliances; * Presence of partial removable dentures; * Oral pathology, chronic disease or tumor(s) of the soft or hard tissues of the oral cavity; 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone); * Five or more carious lesions requiring immediate restorative treatment; * Use of anticonvulsants, sedatives, tranquilizers, anti-inflammatory or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; * Use of antibiotics any time during the one-month period prior to entry into the study; * Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine) and/or on any prescription medicines that might interfere with the study outcome; * Participation in any other clinical study; * Self-reported pregnancy and/or breastfeeding; * Dental prophylaxis within the past three weeks prior to baseline examinations; * Current allergies and/or history of allergic reactions to oral care products, personal care consumer products, or any of their ingredients; * An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours; * Current smokers and/or a history of alcohol or drug abuse
| Facility | City | Country | Status |
|---|---|---|---|
| Consumer Research Consulting, LLC | Melbourne, Florida | United States |