A Clinical Study Investigating the Efficacy of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health

NCT07169188 | Completed

• 1 other identifier: 400031
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2) to improve gingival health and reduce plaque accumulation compared to a regular fluoride toothpaste (reference dentifrice) in participants with localized, plaque-induced, gingivitis.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Mean Bleeding Index (BI) at Week 12

  The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. BI will be assessed on the facial and lingual gingival surfaces of each scorable tooth using a probe. The probe will be gently inserted into the gingival crevice to a depth of approximately 1 millimeter (mm) and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Gingival bleeding will be scored on a 3-points scale with scores ranging from 0 to 2, where 0=Absence of bleeding on probing, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. Mean BI will be calculated by taking the average over all tooth sites assessed for a participant. Lower score indicates improvement in the symptoms.

  Week 12

Secondary Outcomes (8)

• Mean BI at Week 6

  Week 6

• Mean Number of Bleeding Sites (NBS) at Weeks 6 and 12

  Week 6 and Week 12

• Mean Modified Gingival Index (MGI) at Weeks 6 and 12

  Week 6 and Week 12

• Mean Overall Turesky Plaque Index (TPI) at Weeks 6 and 12

  Week 6 and Week 12

• Mean Interproximal TPI at Weeks 6 and 12

  Week 6 and Week 12

Study Arms (2)

Test Toothpaste

EXPERIMENTAL

Participants will brush their teeth with full ribbon of test toothpaste applied on head of toothbrush provided for one timed minute twice a day (morning and evening) for 12 weeks.

Drug: Test Fluoride Toothpaste

Reference Toothpaste

ACTIVE COMPARATOR

Participants will brush their teeth with full ribbon of reference toothpaste applied on head of toothbrush provided for one timed minute twice a day (morning and evening) for 12 weeks.

Drug: Colgate Cavity Protection Toothpaste

Interventions

Test Fluoride Toothpaste DRUG

Toothpaste containing 0.454% SnF2, 0.3% zinc chloride (ZnCl2) and 1% alumina.

Test Toothpaste

Colgate Cavity Protection Toothpaste DRUG

Regular fluoride toothpaste containing 0.76% sodium monofluorophosphate.

Reference Toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided a signed and dated informed consent document indicating that they have been informed of all pertinent aspects of the study before any assessment is performed.
• Participant is of either biological sex and any gender.
• Participant is, at the time of screening, aged 18-70 years, inclusive.
• Participant is willing and able to comply with scheduled visits, treatment plan and all study procedures and Lifestyle Considerations.
• Participant is in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
• Participant with oral health that meets all the following:
• At Visits 1 and 2, has at least 20 natural, permanent teeth (excluding 3rd molars) with at least 40 evaluable surfaces for MGI and TPI assessments.
• At Visit 2, has, in the opinion of the examiner, localized plaque-induced gingivitis with 10-30% bleeding sites from the BI assessment and with an overall TPI score \>= 1.5.

You may not qualify if:

• Participant is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
• Participant has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
• Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• Participant has any other clinical serious or unstable conditions (example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
• Participant is breast feeding or is pregnant (self-reported) or intending to become pregnant over the duration of the study.
• Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Participant is unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
• Participant is a current or ex (stopped within 6 months of Screening) nicotine user, example, smokes, vapes or uses smokeless forms of tobacco such as chewing tobacco, gutka, pan containing tobacco, snus, tobacco pouches etc.
• Participant has diagnosed xerostomia or is taking any medication or has a condition, that in the opinion of the investigator, is causing xerostomia.
• Participant has a medical condition (example, bleeding disorder) which could directly influence gingival bleeding or could affect study outcomes and/or participant safety.
• Participant who has a recent history (within the last year) of alcohol or other substance abuse.
• Participant who has a severe oral condition (example, acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study.
• Participant has a tongue or lip piercing, or any other oral feature that, in the opinion of the investigator, could interfere with the proper usage of a toothbrush or with correct application of study products.
• Participant has/is using the following medications:
• Any antibiotic medication within 28 days prior to screening, or at any time during the study.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

All Sum Research

Mississauga, Ontario, L5N 6J2, Canada

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: September 9, 2025
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

CA (1)