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

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

Recruiting
18-70 years
All
Phase 3

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Overview

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

Eligibility

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

Study details
    Plaque

NCT07398846

Colgate Palmolive

14 May 2026

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