A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices

NCT ID: NCT06140784

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-02
• Study Completion Date: 2023-12-10

Brief Summary

The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.

Conditions

Gingivitis

Study Design

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

Study Groups

0.76% Sodium Monofluorophosphate Dentifrice

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.

Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice

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.

Marketed 0.454% Stannous Fluoride Dentifrice

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 Dentifrice

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.

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

0.454% Stannous Fluoride 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 16 gradable teeth;
• Have mild to moderate gingivitis with at least 20 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;
• Agree to refrain from any oral hygiene the morning of your visit
• Agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing.

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;
• Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UHRG

Whittier, California, United States

Countries

United States

Other Identifiers

2023043

Identifier Type: -

Identifier Source: org_study_id