Stannous fluoride toothpaste, CPC/zinc mouthwash, and battery toothbrush regimen to reduce dental plaque and gingivitis

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.

This will test whether a routine using stannous fluoride toothpaste, a cetylpyridinium chloride (CPC) with zinc mouthwash, and a battery toothbrush can reduce established plaque and gingivitis in adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Colgate Palmolive (Industry-sponsored)
• Locations: 1 site (Melbourne, Florida)
• Trial ID: NCT07398846 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial enrolls adults with established plaque and gingivitis who meet specific plaque and gingival index thresholds and have at least 20 natural teeth. Participants will use an assigned oral care regimen—including a 0.454% stannous fluoride toothpaste, a 0.075% CPC/0.28% zinc lactate mouthwash, and a battery toothbrush—or comparator oral care products for a twelve-week period. Clinical plaque and gingivitis indices will be recorded at baseline and at scheduled follow-up visits to measure change over time. The protocol excludes people with orthodontic appliances, removable partial dentures, advanced periodontal disease, multiple untreated caries, or certain medication use that could affect gingival status.

Who should consider this trial

Good fit: Adults aged 18–70 in good general health with at least 20 permanent natural teeth and measurable gingivitis (Loe and Silness GI ≥ 1.0) and plaque (Rustogi plaque index ≥ 0.6) who can attend a 12-week protocol are ideal candidates.

Not a fit: People with advanced periodontal disease, orthodontic appliances, partial removable dentures, five or more untreated cavities, or those taking disallowed medications (e.g., certain anticonvulsants or sedatives) are excluded and unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, the regimen could produce better plaque control and improved gum health, lowering the risk of worsening gingivitis.

How similar studies have performed: Previous clinical work has shown that stannous fluoride toothpastes and CPC-containing mouthwashes can reduce plaque and gingivitis and that powered toothbrushes often outperform manual brushing, so this approach builds on existing positive evidence.

Eligibility criteria

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

Where this trial is running

Melbourne, Florida

• Consumer Research Consulting, LLC — Melbourne, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Dr. John Gallob, DMD

Conditions Plaque; gingivitis