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

NCT06602466 | Completed Results

• 1 other identifier: 300178
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in participants with plaque-induced mild to moderate gingivitis.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Bleeding Index (BI) at Week 4

  The BI is an invasive assessment of gingival bleeding performed using a round-end probe. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. BI was assessed on 3-points scale 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 was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.

  Week 4

Secondary Outcomes (4)

• Adjusted Mean Number of Bleeding Sites (NBS) at Week 4

  Week 4

• Adjusted Mean Modified Gingival Index (MGI) at Week 4

  Week 4

• Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4

  Week 4

• Adjusted Mean Interproximal TPI at Week 4

  Week 4

Study Arms (2)

Test Toothpaste

EXPERIMENTAL

Participants will brush their teeth with full ribbon of test toothpaste on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.

Drug: Test toothpaste

Reference Toothpaste (Negative Control)

ACTIVE COMPARATOR

Participants will brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.

Drug: Colgate Cavity Protection Toothpaste

Interventions

Test toothpaste DRUG

0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina toothpaste containing 1100 parts per million (ppm) fluoride.

Test Toothpaste

Colgate Cavity Protection Toothpaste DRUG

Commercial toothpaste containing 1450 ppm fluoride.

Reference Toothpaste (Negative Control)

Eligibility Criteria

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

You may qualify if:

• Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• Biological sex at birth was male or female.
• Aged 18 to 70 years inclusive, at the signing of the informed consent.
• Willing and able to comply with scheduled visits, treatment plan, saliva sample collection, study restrictions, Lifestyle Considerations and other study procedures.
• 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 oral health that meets all the following:
• At Screening (Visit 1):
• Participant with at least 20 natural, permanent teeth, (excluding 3rd molars).
• Participant with at least 40 evaluable surfaces for MGI, BI, and TPI.
• A healthy participant with mild to moderate plaque-induced gingivitis in the opinion of the clinical examiner.
• Overall MGI less than or equal to (\<=) 1.75 to \<= 2.30
• At Baseline (Visit 2):
• Overall MGI greater than or equal to (\>=) 1.75 to \<= 2.30
• Overall TPI score \>= 1.5

You may not qualify if:

• 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 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.
• A participant who has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
• A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
• A participant who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to any 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 vaper) who stopped within 6 months of Screening.
• A participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
• A participant who is 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 have directly influenced gingival bleeding.
• A participant who has a bleeding disorder that could have 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 (for 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Birmingham University Dental School

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+441932959500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 17, 2024
• First Posted: September 19, 2024
• Study Start: September 23, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: January 22, 2026
• Results First Posted: January 22, 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

GB (1)