Skip to main content
OpenTrials
Completed

NCT Number: NCT07398846

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Consumer Research Consulting, LLC

Melbourne, Florida, 32935, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.454%Stannous fluoride toothpaste

Drug

toothpaste

0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe

Drug

mouthwash

0.76% Sodium Monofluorophosphate (Na MFP) toothpaste

Drug

toothpaste

0.022% Sodium Fluoride mouthwash

Drug

mouthwash

Primary outcomes

  1. Loe-Silness Gingival Index

    Time frame: Baseline, 6-weeks, and 12-weeks

    score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces

  2. Rustogi Modification of the Navy Plaque Index

    Time frame: Baseline, 6-weeks, and 12-weeks

    a red disclosing solution will be used to make plaque visible and improve scoring accuracy. Subjects will be instructed to swish approximately 10 drops of the solution in their mouth for 10-15 seconds before expectorating.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.