NCT06244303CompletedPhase 3
Clinical Research Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis.
Clinical Research Study to Assess the Efficacy of Two Brushing Regimens: 1) a Toothpaste Containing Stannous Fluoride With a Mouthwash Containing Cetylpyridinium Chloride and a Manual Toothbrush as Compared to 2) a Regular Fluoride Toothpaste and Standard Manual Toothbrush in the Reduction of Established Dental Plaque and Gingivitis.
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1-, 3-, 6-, and 12-weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 29 Jan 2024
- Start date
- Jan 2024
- Primary completion date
- Apr 2024
- Lead sponsor
- Colgate Palmolive
- NCT number
- NCT06244303
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 82
- From Jan 2024 to the primary completion date, Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antibiotic use any time during the one-month period prior to entry into the study.
- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Dental prophylaxis during the past two weeks prior to baseline examinations.
Other illness
- Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
- History of allergies to oral care/personal care consumer products or their ingredients.
- An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
- History of alcohol and/or drug abuse.
Other
- Presence of orthodontic appliances.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Five or more carious lesions requiring immediate restorative treatment.
- On any prescription medicines that might interfere with the study outcome.
- Self-reported pregnancy and/or lactating subjects
Who the study is looking for
- 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 plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification)
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mesa Dental Centre Coordinator of this site? Confirm its status | Costa Mesa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.