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

Phase 4

Completed

• Conditions: Gingivitis
• Interventions: Drug: Marketed Toothpaste; Drug: Marketed Cavity Protection Toothpaste

• Registration Number: NCT03936569
• Lead Sponsor: Procter and Gamble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-29
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marketed Stannous Fluoride Toothpaste	Marketed Toothpaste	Brush twice daily
Marketed Cavity Protection Toothpaste	Marketed Cavity Protection Toothpaste	Brush twice daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Turesky Modified Quigley-Hein Index	3 Months	The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).

Trial Locations

Locations (1)

Silverstone Research Group; 🇺🇸 Las Vegas, Nevada, United States