N/A
N=196
A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation
Dental Plaque · Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT06660069 ↗Enrolled (actual)
196
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste) — 10.1; 24.1 bleeding sites — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stannous Fluoride Toothpaste (Parodontax Complete Protection Toothpaste) (Drug); CPC Mouthwash (Parodontax Active Gum Health Mouthwash) (Drug); Regular Fluoride Toothpaste (Crest Cavity Protection) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste) |
10.1; 24.1 | <0.0001 sig |
| SECONDARY Interproximal NBS at Week 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) |
4.5; 15.0 | <0.0001 sig |
| SECONDARY Overall NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) |
10.6; 25.0 | <0.0001 sig |
| SECONDARY Interproximal NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) |
5.1; 15.4 | <0.0001 sig |
| SECONDARY Mean Overall Bleeding Index (Bl) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) |
0.08; 0.20; 0.08; 0.19 | <0.0001 sig |
| SECONDARY Mean Interproximal BI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) |
0.06; 0.18; 0.05; 0.17 | <0.0001 sig |
| SECONDARY Mean Overall Modified Gingival Index (MGI) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) |
0.93; 1.43; 0.78; 1.31 | <0.0001 sig |
| SECONDARY Mean Interproximal MGI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) |
1.13; 1.62; 0.97; 1.49 | <0.0001 sig |
| SECONDARY Mean Overall Turesky Plaque Index (TPI) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) |
2.59; 2.95; 2.38; 2.83 | 0.0001 sig |
| SECONDARY Mean Interproximal TPI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) |
2.88; 3.19; 2.69; 3.10 | <0.0001 sig |
| SECONDARY Overall NBS at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) |
14.1; 25.0; 11.4; 24.1 | <0.0001 sig |
| SECONDARY Interproximal NBS at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) |
7.8; 15.4; 6.1; 15.0 | <0.0001 sig |
| SECONDARY Mean Overall BI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) |
0.11; 0.20; 0.08; 0.19 | <0.0001 sig |
| SECONDARY Mean Interproximal BI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) |
0.09; 0.18; 0.06; 0.17 | <0.0001 sig |
| SECONDARY Mean Overall MGI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) |
1.11; 1.43; 0.88; 1.31 | <0.0001 sig |
| SECONDARY Mean Interproximal MGI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) |
1.31; 1.62; 1.06; 1.49 | <0.0001 sig |
| SECONDARY Mean Overall TPI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) |
2.88; 2.95; 2.74; 2.83 | 0.8986 |
| SECONDARY Mean Interproximal TPI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) |
3.15; 3.19; 3.02; 3.10 | 0.8658 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 ul
Data sourced from ClinicalTrials.gov (NCT06660069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.