A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Drug: 0.76% Sodium Monofluorophosphate Dentifrice; Drug: 1.15% Sodium Monofluorophosphate Dentifrice; Drug: 0.454% Stannous Fluoride Dentifrice

• Registration Number: NCT06140771
• Lead Sponsor: Procter and Gamble

Brief Summary

The objective of this learning clinical study is to assess the gingivitis effects of four different dentifrices over a 3-month period.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-20
• Primary Completion: 2022-02-06
• Study Completion: 2022-02-06
• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-20
• Last Update Posted: 2023-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.76% Sodium Monofluorophosphate Dentifrice	0.76% Sodium Monofluorophosphate Dentifrice	-
1.15% Sodium Monofluorophosphate Dentifrice	1.15% Sodium Monofluorophosphate Dentifrice	-
Marketed 0.454% Stannous Fluoride Dentifrice	0.454% Stannous Fluoride Dentifrice	-
0.454% Stannous Fluoride Dentifrice	0.454% Stannous Fluoride Dentifrice	-

Primary Outcome Measures

Name	Time	Method
Löe-Silness Gingivitis Evaluation	3 Months	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).

Secondary Outcome Measures

Name	Time	Method
Löe-Silness Gingivitis Evaluation	1 Month	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).

Trial Locations

Locations (1)

UHRG; 🇺🇸 Whittier, California, United States