A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation

NCT06660069 | Completed Results

• 1 other identifier: 300211
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the ability of a marketed Cetylpyridinium Chloride (CPC) mouthwash alongside a marketed Stannous Fluoride (SnF2) toothpaste in improving gingival health and reducing plaque accumulation, compared to the use of a regular fluoride toothpaste alone in participants with clinically measurable plaque-induced gingivitis.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste)

  Gingival bleeding was assessed according to the expanded bleeding index (EBI), by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth were assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing.

  Week 12

Secondary Outcomes (17)

• Interproximal NBS at Week 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste)

  Week 12

• Overall NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste)

  Week 6

• Interproximal NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste)

  Week 6

• Mean Overall Bleeding Index (Bl) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste)

  Week 6 and Week 12

• Mean Interproximal BI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste)

  Week 6 and Week 12

Study Arms (3)

Toothpaste/Mouthwash (SnF2 Toothpaste followed by CPC Mouthwash)

EXPERIMENTAL

Participants will brush their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants will swish 20 milliliters (mL) of the mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks.

Drug: Stannous Fluoride Toothpaste (Parodontax Complete Protection Toothpaste); Drug: CPC Mouthwash (Parodontax Active Gum Health Mouthwash)

Negative Control Toothpaste (Sodium Fluoride Toothpaste)

ACTIVE COMPARATOR

Participants will brush their teeth with full ribbon of negative control toothpaste containing sodium fluoride on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks.

Drug: Regular Fluoride Toothpaste (Crest Cavity Protection)

Reference Toothpaste (SnF2 Toothpaste)

ACTIVE COMPARATOR

Participants will brush their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks.

Drug: Stannous Fluoride Toothpaste (Parodontax Complete Protection Toothpaste)

Interventions

CPC Mouthwash (Parodontax Active Gum Health Mouthwash) DRUG

Mouthwash containing 0.07% w/w CPC.

Toothpaste/Mouthwash (SnF2 Toothpaste followed by CPC Mouthwash)

Regular Fluoride Toothpaste (Crest Cavity Protection) DRUG

Toothpaste containing 0.243% w/w sodium fluoride.

Negative Control Toothpaste (Sodium Fluoride Toothpaste)

Stannous Fluoride Toothpaste (Parodontax Complete Protection Toothpaste) DRUG

Toothpaste containing 0.454 percent (%) weight by weight (w/w) SnF2.

Toothpaste/Mouthwash (SnF2 Toothpaste followed by CPC Mouthwash)

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.
• Participant oral health that meets all the following:
• AT SCREENING (Visit 1):
• Participant with at least 20 natural, permanent teeth.
• Participant with at least 40 evaluable surfaces for MGI, BI, and TPI.
• A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the Screening Visit.
• AT BASELINE (Visit 2; Prior to Dental Prophylaxis):
• A participant with 10% - 30% bleeding sites.
• A participant with mean interproximal whole mouth TPI score \>=1.5.

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 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 (example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
• 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, 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 (example, type 2 diabetes).
• 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 (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)

Salus Research

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

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: October 24, 2024
• First Posted: October 26, 2024
• Study Start: November 18, 2024
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

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)