A Three-Month Clinical Study to Assess the Gingivitis Effects of Various Dentifrices
| Registry | NCT06140771 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 115 (Actual) |
| Sponsor | Procter and Gamble (Industry) |
| Conditions | Gingivitis |
| Interventions | 0.76% Sodium Monofluorophosphate Dentifrice, 1.15% Sodium Monofluorophosphate Dentifrice, 0.454% Stannous Fluoride Dentifrice (Drug) |
| Dates | start 2021-10-20, primary completion 2022-02-06, completion 2022-02-06, first posted 2023-11-20, last updated 2023-11-20 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Gingivitis All trials of 0.76% Sodium Monofluorophosphate Dentifrice All trials of 1.15% Sodium Monofluorophosphate Dentifrice
The objective of this learning clinical study is to assess the gingivitis effects of four different dentifrices over a 3-month period.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 0.76% Sodium Monofluorophosphate Dentifrice | Sham comparator | Drug: 0.76% Sodium Monofluorophosphate Dentifrice | |
| 1.15% Sodium Monofluorophosphate Dentifrice | Sham comparator | Drug: 1.15% Sodium Monofluorophosphate Dentifrice | |
| Marketed 0.454% Stannous Fluoride Dentifrice | Active comparator | Drug: 0.454% Stannous Fluoride Dentifrice | |
| 0.454% Stannous Fluoride Dentifrice | Active comparator | Drug: 0.454% Stannous Fluoride Dentifrice |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Be at least 18 years of age; * Provide written informed consent prior to participation and be given a signed copy of the informed consent form; * Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; * Have at least 16 gradable teeth; * Have mild to moderate gingivitis with a range of 10% to 70% bleeding sites; * Agree to return for scheduled visits and follow the study procedures; * Agree to refrain from use of any non-study oral hygiene products for the duration of the study; * Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study. Exclusion Criteria: * Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit; * Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; * Removable oral appliances; * Fixed facial or lingual orthodontic appliances; * Self-reported pregnancy or lactation; * Any diseases or condition that might interfere with the safe participation in the study; and * Inability to undergo study procedures.
| Facility | City | Country | Status |
|---|---|---|---|
| UHRG | Whittier, California | United States |