RecruitingPhase 3NCT07398846

Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established 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.


Sponsor

Colgate Palmolive

Enrollment

135 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

  • 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 Criteria13

  • 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

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Interventions

DRUG0.454%Stannous fluoride toothpaste

toothpaste

DRUG0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe

mouthwash

DRUG0.76% Sodium Monofluorophosphate (Na MFP) toothpaste

toothpaste

DRUG0.022% Sodium Fluoride mouthwash

mouthwash


Locations(1)

Consumer Research Consulting, LLC

Melbourne, Florida, United States

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NCT07398846


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