Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT06660069
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.
Detailed Description:
This will be a single center, 12-week, randomized, controlled, examiner-blind, 3-treatment arm, parallel group, stratified (by sex \[male/female\]) study to evaluate the efficacy of using the SnF2 toothpaste/CPC mouthwash twice daily in reducing gingivitis and plaque accumulation in a population with clinically measurable levels of gingivitis. The clinical efficacy of the commercially available SnF2 toothpaste/CPC mouthwash will be compared with that of a commercially available, regular fluoride toothpaste with no known anti-gingivitis nor anti-plaque efficacy properties (negative control). This study will also explore whether a CPC mouthwash used with a SnF2 toothpaste could provide benefits in plaque accumulation reduction and gingival health improvement over the sole use of SnF2 toothpaste (reference product). Sufficient participants will be screened to randomize approximately 198 participants (approximately 66 per group) to ensure approximately 180 evaluable participants (approximately 60 per group) complete the study.
Study:
NCT06660069
Study Brief:
Protocol Section:
NCT06660069