A 3-Month Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice

Procter and Gamble1 site in 1 country90 target enrollmentOctober 29, 2018

ConditionsGingivitis

InterventionsMarketed Toothpaste Marketed Cavity Protection Toothpaste

DrugsMarketed Toothpaste Marketed Cavity Protection Toothpaste

Overview

Phase: Phase 4
Intervention: Marketed Toothpaste
Conditions: Gingivitis
Sponsor: Procter and Gamble
Enrollment: 90
Locations: 1
Primary Endpoint: Löe-Silness Gingivitis Evaluation
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.

Registry

clinicaltrials.gov

Start Date

October 29, 2018

End Date

January 25, 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Procter and Gamble

Responsible Party

Sponsor

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;
•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.

Arms & Interventions

Marketed Stannous Fluoride Toothpaste

Brush twice daily

Intervention: Marketed Toothpaste

Marketed Cavity Protection Toothpaste

Brush twice daily

Intervention: Marketed Cavity Protection Toothpaste

Outcomes

Primary Outcomes

Löe-Silness Gingivitis Evaluation

Time Frame: 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).