A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

Sponsor

Procter and Gamble (Industry)

Overall Status

Completed

CT.gov ID

NCT06140771

Collaborator

(none)

115

Enrollment

Location

Arms

3.6

Actual Duration (Months)

32.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Drug: 0.76% Sodium Monofluorophosphate Dentifrice Drug: 1.15% Sodium Monofluorophosphate Dentifrice Drug: 0.454% Stannous Fluoride Dentifrice Drug: 0.454% Stannous Fluoride Dentifrice	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 20, 2021

Actual Primary Completion Date :

Feb 6, 2022

Actual Study Completion Date :

Feb 6, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Löe-Silness Gingivitis Evaluation [Baseline]
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).
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UHRG	Whittier	California	United States	90602

Sponsors and Collaborators

Procter and Gamble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Procter and Gamble

ClinicalTrials.gov Identifier:

NCT06140771

Other Study ID Numbers:

2021080

First Posted:

Nov 20, 2023

Last Update Posted:

Nov 20, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 20, 2023