Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste

Phase 3

Completed

• Conditions: Plaque, Dental; Gingivitis
• Interventions: Drug: Test; Drug: Control

• Registration Number: NCT06300866
• Lead Sponsor: Colgate Palmolive

Brief Summary

The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-18
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-08
• Status Verified: 2024-03
• Study First Submitted: 2024-03-03
• Study First Submitted QC: 2024-03-03
• Last Update Submitted: 2024-03-03
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Potential subjects must meet all of the following criteria
• Subjects, ages 18-70, inclusive
• Availability for the six-month duration of the clinical research study
• Good general health
• Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
• Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index
• Signed Informed Consent Form

Exclusion Criteria

• Presence of orthodontic appliances
• Presence of partial removable dentures
• Tumor(s) of the soft or hard tissues of the oral cavity
• Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
• Five or more carious lesions requiring immediate restorative treatment
• Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study
• Dental prophylaxis during the past two weeks prior to baseline examinations
• History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome
• An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours
• History of alcohol and/or drug abuse
• Self-reported pregnancy and/or lactating subjects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Test	toothpaste brushing 2x daily morning \& evening for 2 minutes
Group II	Control	toothpaste brushing 2x daily morning \& evening for 2 minutes
Group I	Control	toothpaste brushing 2x daily morning \& evening for 2 minutes
Group II	Test	toothpaste brushing 2x daily morning \& evening for 2 minutes

Primary Outcome Measures

Name	Time	Method
Whole-Mouth Gingivitis Measurement	baseline, 3 months and 6 months	difference of reduction in gingival index
Whole-Mouth Dental Plaque Measurement	baseline, 3 months and 6 months	difference of reduction in plaque index

Trial Locations

Locations (1)

Loma Linda University School of Dentistry; 🇺🇸 Loma Linda, California, United States