A Clinical Study to Evaluate the Effectiveness of an Experimental Toothpaste in Improving Gum Health and Reducing Plaque Accumulation

NCT07255040 | Recruiting

• 1 other identifier: 400034
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this 24-week clinical study is to evaluate the ability of an experimental dentifrice containing 0.454 percent (%) weight by weight (w/w) Stannous fluoride (SnF2); to improve gingival health, plaque reduction and prevention of plaque accumulation compared with a regular fluoride dentifrice (negative control) in participants with mild to moderate gingivitis.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Number of Bleeding Sites (Overall) at Week 24

  Number of bleeding sites will be assessed using the bleeding index (BI) assessment. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 millimeter (mm) into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. The number of bleeding sites for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.

  Week 24

Secondary Outcomes (10)

• Number of Bleeding Sites (Overall) at Weeks 1, 4 and 12

  Weeks 1, 4 and 12

• Number of Bleeding Sites (Interproximal) at Weeks 1, 4 and 12

  Weeks 1, 4 and 12

• Number of Bleeding Sites (Interproximal) at Week 24

  Week 24

• Mean BI (Overall) at Weeks 1, 4, 12 and 24

  Weeks 1, 4, 12 and 24

• Mean BI (Interproximal) at Weeks 1, 4, 12 and 24

  Weeks 1, 4, 12 and 24

Study Arms (3)

Test Dentifrice

EXPERIMENTAL

Participants will be instructed to brush their teeth thoroughly with Test Dentifrice for at least one (timed) minute twice a day (morning and evening) for 24 weeks.

Drug: Test Dentifrice

Reference Dentifrice (Positive Control)

ACTIVE COMPARATOR

Participants will be instructed to brush their teeth thoroughly with Reference Dentifrice (Positive Control) for at least one (timed) minute twice a day (morning and evening) for 24 weeks.

Drug: Parodontax Complete Protection

Reference Dentifrice (Negative Control)

ACTIVE COMPARATOR

Participants will be instructed to brush their teeth thoroughly with Reference Dentifrice (Negative Control) for at least one (timed) minute twice a day (morning and evening) for 24 weeks.

Drug: Colgate Cavity Protection

Interventions

Parodontax Complete Protection DRUG

Marketed dentifrice containing 0.454% w/w SnF2.

Reference Dentifrice (Positive Control)

Colgate Cavity Protection DRUG

Marketed regular fluoride dentifrice.

Reference Dentifrice (Negative Control)

Test Dentifrice DRUG

Experimental dentifrice containing 0.454% w/w SnF2.

Test 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 has been informed of all pertinent aspects of the study before any assessment is performed.
• Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive.
• A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
• 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 individual'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, 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 female participant who is a pregnant (self-reported) or intending to become pregnant over the duration of the study or 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 or who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
• A participant who is diagnosed with 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 (example, type 2 diabetes) or 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 (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.
• Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.
• A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
• A participant who has dentures (partial or full).
• A participant who has fixed orthodontic appliances or is undergoing active or recent (within 3 months of Screening) orthodontic treatment, which in the opinion of the investigator, could interfere with study procedures, assessments or outcomes.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

RECRUITING

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

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

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: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

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)