A Three Month Bleeding-Model Clinical Study

Gingivitis Clinical Trial

Official title:

A Three-Month Bleeding-Model Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05916521
• Other study ID #: 2021086
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: June 2023
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

• Having an inability to undergo study procedures.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• 0.454% stannous fluoride
Brush two times daily
• 0.76% sodium monofluorophosphate
Brush two times daily
• 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM
Brush two times daily

Locations

Country	Name	City	State
United States	Silverstone Research Group	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Löe-Silness Gingivitis Evaluation	Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).	Baseline
Primary	Löe-Silness Gingivitis Evaluation	Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).	Week 4
Primary	Löe-Silness Gingivitis Evaluation	Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).	Week 12