A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

NCT ID: NCT06140771

Last Updated: 2023-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2022-02-06

Brief Summary

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

Conditions

Gingivitis

Study Design

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

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.

1.15% Sodium Monofluorophosphate Dentifrice

Group Type: SHAM_COMPARATOR

1.15% 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 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

1.15% 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

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 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.

• 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

2021080

Identifier Type: -

Identifier Source: org_study_id