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Completed

NCT Number: NCT07640399

Stannous Fluoride Toothpaste for Reduction and Treatment of Gingivitis

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).

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Key information

Conditions

Gingival Inflammation Bleeding Gingival Diseases Gingivitis Hemorrhage Infections Mouth Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Periodontal Diseases Plaque Plaque, Amyloid Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All Sum

Mississauga, Ontario, L5N 6J2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Fluoride Dentifrice

Drug

Comparator toothpaste

Stannous Fluoride Toothpaste (SnF)

Drug

Test toothpaste (0.454% SnF)

Primary outcomes

  1. Evaluate the efficacy of a stannous fluoride toothpaste in gingival inflammation

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: 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. Evaluate improvements at weeks 2, 4, 8; assess plaque control at weeks 2, 4, 8, and 12 weeks

    Time frame: 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.

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

    Time frame: 2, 4, and 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Church & Dwight Company, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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