A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06140771
• Other study ID #: 2021080
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: February 6, 2022

Study information

• Verified date: November 2023
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: February 6, 2022
• Est. primary completion date: February 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• 0.76% Sodium Monofluorophosphate Dentifrice
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
• 1.15% Sodium Monofluorophosphate Dentifrice
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
• 0.454% Stannous Fluoride Dentifrice
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
• 0.454% Stannous Fluoride Dentifrice
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

Locations

Country	Name	City	State
United States	UHRG	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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