Stannous Fluoride Toothpaste for Reduction and Treatment of Gingivitis

Efficacy of a Stannous Fluoride Toothpaste in the Reduction and Treatment of Gingivitis: A Randomized Controlled Trial

This study evaluated the efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste in reducing gingivitis, bleeding, and plaque over a 12-week period.

A total of 132 subjects were randomized to one of two treatment groups and assessed at baseline and at Weeks 2, 4, 8, and 12 using standardized clinical indices, including the Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI).

Study Overview

• Status: Completed
• Conditions: Bleeding; Plaque; Gingival Inflammation
• Intervention / Treatment: Drug: Stannous Fluoride Toothpaste (SnF); Drug: Sodium Fluoride Dentifrice

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5N 6J2
      • All Sum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female subjects aged 18 to 65 years (inclusive)
• Provided written informed consent prior to participation
• Able to brush their own teeth on a daily basis
• In good general health based on medical history review
• Minimum of at least 18 natural, scorable teeth
• Mean plaque index score ≥ 1.95
• Mean baseline gingival index score ≥ 1.70 and ≤ 3.0
• Agreed to refrain from use of all oral hygiene products other than those supplied for the study
• Agreed to refrain from oral hygiene, eating, drinking, and chewing gum for approximately 12 hours prior to study visits
• Agreed not to undergo dental prophylaxis or elective dental procedures during the study
• Willing and able to comply with study procedures and visit schedule

Exclusion Criteria:

• Physical limitations or restrictions that preclude normal tooth brushing
• Requirement for premedication prior to dental treatment
• Pregnancy or intent to become pregnant during the study period
• Use of tobacco or nicotine products
• Poor oral hygiene defined as >40 bleeding sites
• Presence of dental caries or calculus deposits that may interfere with plaque assessments
• Major oral hard or soft tissue lesions or trauma at baseline
• Presence of fixed or removable orthodontic appliances
• Dental prophylaxis within 1 month prior to baseline visit
• History of significant adverse events, allergy, or irritation related to oral hygiene products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sodium Fluoride Control Dentifrice; Dentifrice containing sodium fluoride, serving as the control comparator	Drug: Sodium Fluoride Dentifrice; Comparator toothpaste
Experimental: Stannous Fluoride Toothpaste; Dentifrice containing stannous fluoride evaluated for gingivitis effect	Drug: Stannous Fluoride Toothpaste (SnF); Test toothpaste (0.454% SnF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the efficacy of a stannous fluoride toothpaste in gingival inflammation	Change from baseline in whole-mouth Modified Gingival Index (MGI) score at Week 12 Whole-mouth gingival inflammation will be assessed using the Modified Gingival Index (MGI). Scores are recorded on scorable gingival areas of all scorable teeth using a 0-4 scale, and the whole-mouth MGI score is calculated as the sum of all site scores divided by the number of scorable sites examined. The primary analysis compares the change from baseline to Week 12 between treatment groups.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate improvements at weeks 2, 4, 8; assess gingival bleeding at weeks 2, 4, 8, and 12 weeks	Secondary outcome measures include change from baseline in whole-mouth bleeding index at Weeks 2, 4, 8, and 12...based on scorable gingival areas using the Saxton 0-2 scale	2, 4, 8, and 12 weeks
Evaluate improvements at weeks 2, 4, 8; assess plaque control at weeks 2, 4, 8, and 12 weeks	Secondary outcome measures include change from baseline in plaque at Weeks 2, 4, 8, and 12...calculated from disclosed plaque scores on scorable buccal and lingual tooth surfaces using the Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index; lower scores indicate improvement for all measures.	2, 4, 8, and 12 weeks
Evaluate improvements at weeks 2, 4, 8; in whole mouth Modified Gingival Index (MGI) scores	Secondary outcome measures include change from baseline in whole-mouth MGI at Weeks 2, 4, and 8, using the Modified Gingival Index (MGI). Scores are recorded on scorable gingival areas of all scorable teeth using a 0-4 scale, and the whole-mouth MGI score is calculated as the sum of all site scores divided by the number of scorable sites examined.	2, 4, and 8 weeks

Collaborators and Investigators

• Sponsor: Church & Dwight Company, Inc.
• Investigators: Study Director: Annahita Ghassemi, Church & Dwight, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Actual): June 13, 2025
• Study Completion (Actual): June 13, 2025

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Infections; Gingival Diseases; Pathological Conditions, Signs and Symptoms; Hemorrhage; Plaque, Amyloid; Gingivitis
• Other Study ID Numbers: ST-25-U01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The sponsor does not plan to share individual participant data. Summary results will be provided as required, but no de identified datasets will be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No