A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

A Three-Month Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

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

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: 0.76% Sodium Monofluorophosphate Dentifrice; Drug: 1.15% Sodium Monofluorophosphate Dentifrice; Drug: 0.454% Stannous Fluoride Dentifrice

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Whittier, California, United States, 90602
      • UHRG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 0.76% Sodium Monofluorophosphate Dentifrice	Drug: 0.76% Sodium Monofluorophosphate Dentifrice; Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Sham Comparator: 1.15% Sodium Monofluorophosphate Dentifrice	Drug: 1.15% Sodium Monofluorophosphate Dentifrice; Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Active Comparator: Marketed 0.454% Stannous Fluoride Dentifrice	Drug: 0.454% Stannous Fluoride Dentifrice; Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Active Comparator: 0.454% Stannous Fluoride Dentifrice	Drug: 0.454% Stannous Fluoride Dentifrice; Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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).	1 Month

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): February 6, 2022
• Study Completion (Actual): February 6, 2022

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Actual): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Tin Fluorides; Fluorophosphate
• Other Study ID Numbers: 2021080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No