Stannous Fluoride Toothpaste for Reduction and Treatment of Gingivitis

NCT07640399 | Completed

• 1 other identifier: ST-25-U01
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Plaque; Bleeding; Gingival Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluate improvements at weeks 2, 4, 8; assess gingival bleeding at weeks 2, 4, 8, and 12 weeks

  2, 4, 8, and 12 weeks

• Evaluate improvements at weeks 2, 4, 8; assess plaque control at weeks 2, 4, 8, and 12 weeks

  2, 4, 8, and 12 weeks

• Evaluate improvements at weeks 2, 4, 8; in whole mouth Modified Gingival Index (MGI) scores

  2, 4, and 8 weeks

Study Arms (2)

Sodium Fluoride Control Dentifrice

ACTIVE COMPARATOR

Dentifrice containing sodium fluoride, serving as the control comparator

Drug: Sodium Fluoride Dentifrice

Stannous Fluoride Toothpaste

EXPERIMENTAL

Dentifrice containing stannous fluoride evaluated for gingivitis effect

Drug: Stannous Fluoride Toothpaste (SnF)

Interventions

Sodium Fluoride Dentifrice DRUG

Comparator toothpaste

Sodium Fluoride Control Dentifrice

Stannous Fluoride Toothpaste (SnF) DRUG

Test toothpaste (0.454% SnF)

Stannous Fluoride Toothpaste

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

All Sum

Mississauga, Ontario, L5N 6J2, Canada

Location

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid; Hemorrhage

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Annahita Ghassemi

  Church & Dwight, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 10, 2026
• Study Start: March 17, 2025
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)