Brief Title: a Clinical Study to Assess Gingivitis

NCT ID: NCT06659471

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2022-06-06

Brief Summary

The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.

Conditions

Gingival Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.76% Sodium Monofluorophosphate

0.76% Sodium Monofluorophosphate

Group Type: SHAM_COMPARATOR

0.76% Sodium Monofluorophosphate Dentifrice

Intervention Type: DRUG

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

0.454% Stannous Fluoride

0.454% Stannous Fluoride

Group Type: ACTIVE_COMPARATOR

0.454% Stannous Fluoride Dentifrice

Intervention Type: DRUG

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

0.454% Stannous Fluoride, 4.7 pH

0.454% Stannous Fluoride, 4.7 pH

Group Type: EXPERIMENTAL

0.454% Stannous Fluoride Dentifrice

Intervention Type: DRUG

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

0.454% Stannous Fluoride, 5.8 pH

0.454% Stannous Fluoride, 5.8 pH

Group Type: EXPERIMENTAL

0.454% Stannous Fluoride Dentifrice

Intervention Type: DRUG

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

Interventions

0.76% Sodium Monofluorophosphate Dentifrice

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

Intervention Type: DRUG

0.454% Stannous Fluoride Dentifrice

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

Intervention Type: DRUG

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;
• Having an inability to undergo study procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Silverstone Research

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

2021117

Identifier Type: -

Identifier Source: org_study_id