Brief Title: a Clinical Study to Assess Gingivitis | NCT06659471 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 26, 2024
Brief Title: a Clinical Study to Assess Gingivitis
A Three-Month Bleeding Model Clinical Study
ClinicalTrials.gov ID
NCT06659471
Lead Sponsor
Procter and GambleINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
120Actual
Last Update Posted
Oct 26, 2024Actual
Start Date
Mar 7, 2022Actual
Primary Completion Date
Jun 6, 2022Actual
Completion Date
Jun 6, 2022Actual
Official Title
A Three-Month Bleeding Model Clinical Study
Brief Summary
The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.
Gingival Diseases
0.76% Sodium Monofluorophosphate Dentifrice
0.454% Stannous Fluoride Dentifrice
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 20 gradable teeth;
Have established gingivitis with 10-70 % 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 medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
Having 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;
Having known hypersensitivity to the test products;
Having removable oral appliances;
Having fixed facial or lingual orthodontic appliances;
Self-reported pregnancy or lactation;
Having any diseases or condition that might interfere with the safe participation in the study;