A Study to Investigate the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health

NCT07704905 | Not Yet Recruiting

• 1 other identifier: 400347
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study will be to evaluate the ability of using an experimental dentifrice containing 0.454 percent (%) weight for weight (w/w) Stannous Fluoride (SnF2) to reduce gingivitis and plaque accumulation, compared with a regular fluoride toothpaste (negative control) in participants with mild to moderate gingivitis.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Overall Modified Gingival Index (MGI) at Week 8

  The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed on all scorable teeth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0 equals (=) Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal/ papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal/ papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal/ papillary gingival unit, 4= Severe inflammation; marked redness, edema and/ or hypertrophy of the marginal/ papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from Baseline= Week 8 score minus Baseline score. Lower scores indicate symptom improvement.

  Baseline and Week 8

Secondary Outcomes (3)

• Change from Baseline in Interproximal MGI at Week 8

  Baseline and Week 8

• Change from Baseline in Overall Turesky Modification of the Quigley Hein Plaque Index (TPI) at Week 8

  Baseline and Week 8

• Change from Baseline in Interproximal TPI at Week 8

  Baseline and Week 8

Study Arms (2)

Test Dentifrice

EXPERIMENTAL

Participants will brush their teeth thoroughly for at least one timed minute twice daily (morning and evening) for 8 Weeks, using a full ribbon of Test Dentifrice on the head of the toothbrush provided.

Drug: Test Dentifrice

Reference Dentifrice

ACTIVE COMPARATOR

Participants will brush their teeth thoroughly for at least one timed minute twice daily (morning and evening) for 8 Weeks, using a full ribbon of Reference Dentifrice on the head of the toothbrush provided.

Drug: Reference Dentifrice (Colgate Cavity Protection Dentifrice)

Interventions

Test Dentifrice DRUG

Experimental dentifrice containing 0.454% w/w SnF2.

Test Dentifrice

Reference Dentifrice (Colgate Cavity Protection Dentifrice) DRUG

A marketed regular fluoride dentifrice.

Reference Dentifrice

Eligibility Criteria

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

You may qualify if:

• Participant provision of a signed and dated informed consent document indicating that the participant will have been informed of all pertinent aspects of the study before any assessment is performed.
• A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures, study restrictions, Lifestyle considerations.
• A participant 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 participant's ability to understand and follow study procedures and requirements.

You may not qualify if:

• A participant who 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.
• A participant who 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.
• A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (Example(e.g.), cardiovascular diseases, diabetes, liver disorders, and kidney disorders) 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.
• A participant who is a pregnant female (self-reported) or intending to become pregnant over the duration of the study.
• A female participant who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• A participant unwilling or unable to comply with the lifestyle considerations described in this protocol.
• A participant who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening.
• A participant who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, paan containing tobacco, nicotine-based e-cigarettes).
• A participant who has diagnosed xerostomia or is taking any medication that in the view of the investigator, is causing xerostomia.
• A participant who has a medical condition which could directly influenced gingival bleeding (e.g., type 2 diabetes).
• A participant who has a bleeding disorder that could affected study outcomes and/or participant safety.
• A participant who has a recent history (within the last year) of alcohol or other substance abuse.
• A participant who has a severe oral condition (e.g., 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.
• Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Salus Research Inc

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeffery L Milleman, DDS

  Salus Research Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haleon Response Center

CONTACT

+441932959500; ww.clinical-trial-register@haleon.com

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: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

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

US (1)