A Clinical Study to Evaluate the Efficacy of a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation

NCT06933368 | Completed

• 1 other identifier: 300268
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this 12-week clinical study is to evaluate the ability of an experimental mouthwash, containing 0.085 percent (%) Cetylpyridinium chloride (CPC) as an adjunct to toothbrushing with a regular fluoride toothpaste, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste alone in participants with plaque-induced mild to moderate gingivitis.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Number of Bleeding Sites (Overall) At Week 12

  Gingival bleeding will be 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 degree, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth will be assessed. All scorable teeth in one quadrant will be probed first (approximately 30 seconds) before recording the number of gingival units which bleed. The number of bleeding sites is calculated as the number of evaluable tooth sites (having 2/3rds of the natural tooth surface gradable for assessment) with bleeding observed immediately on probing or within 30 seconds of probing.

  Week 12

Secondary Outcomes (9)

• Number of Bleeding Sites (Interproximal) At Week 12

  Week 12

• Number of Bleeding Sites (Overall) At Week 6

  Week 6

• Number of Bleeding Sites (Interproximal) At Week 6

  Week 6

• Mean EBI (Overall) At Week 6 and Week 12

  Week 6 and Week 12

• Mean EBI (Interproximal) At Week 6 and Week 12

  Week 6 and Week 12

Study Arms (2)

Test Products (Toothpaste + Mouthwash)

EXPERIMENTAL

Participants will be instructed to brush their teeth with the toothpaste (Crest Cavity Protection) for at least one minute twice daily (morning and evening) for 12 weeks. After each brushing, participants will swish 20 milliliter (ml) of experimental mouthwash for 30 seconds without rinsing with water after use of mouthwash.

Drug: Crest Cavity Protection Toothpaste; Drug: Experimental Mouthwash

Reference Product (Toothpaste)

ACTIVE COMPARATOR

Participants will be instructed to brush their teeth with the toothpaste (Crest Cavity Protection) for at least one minute twice daily (morning and evening) for 12 weeks.

Drug: Crest Cavity Protection Toothpaste

Interventions

Crest Cavity Protection Toothpaste DRUG

Toothpaste containing 0.243% w/w NaF.

Reference Product (Toothpaste); Test Products (Toothpaste + Mouthwash)

Experimental Mouthwash DRUG

Mouthwash containing 0.085% w/w CPC.

Test Products (Toothpaste + 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, bleeding index (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% to 30% bleeding sites.
• A participant with overall 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, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (for 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 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 (for 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 (for 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 (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.
• 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

Interventions

hydrated silica gel-based toothpaste

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: April 16, 2025
• First Posted: April 18, 2025
• Study Start: April 21, 2025
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

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)