NCT06607263

Comparative Study of CPC+Zn Mouthwash, Dental Floss, and Essential Oils Mouthwash on Plaque and Gingivitis Reduction

Clinical Study to Evaluate the Efficacy of Rinsing With an Alcohol Free Mouthwash Containing CPC+Zn as Compared to Dental Flossing and to Rising With an Essential Oils Containing Alcohol Mouthwash in Reducing Dental Plaque and Gingivitis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Clinical study evaluating the effectiveness of an alcohol-free mouthwash containing CPC+Zn compared to dental flossing and an essential oils-containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, single-center, double-blind trial with a parallel design. It involves 120 participants aged between 18 and 65, randomized into different groups, and spans 12 weeks.

Detailed description

This clinical study aims to evaluate the efficacy of an alcohol-free mouthwash containing CPC (Cetylpyridinium Chloride) and Zinc (Zn) in reducing dental plaque and gingivitis compared to dental flossing and a mouthwash with essential oils in an alcohol base. It is a Phase III, randomized, double-blind, parallel-group trial involving 120 participants aged 18 to 65. Subjects will be divided into three groups-one using the CPC+Zn mouthwash, another using the essential oils mouthwash, and a control group using dental floss. Each group will also use a fluoride toothpaste and a soft-bristle toothbrush twice daily over 12 weeks. The primary efficacy variable is the reduction of gingival inflammation also Probing Depth, Bleeding on Probing, and a Plaque Index will be accessed. Subjects will undergo baseline, 4-week, and 12-week evaluations, with data analyzed using ANCOVA to assess the efficacy and safety of the products. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants. The study rigorous design aims to provide comprehensive insights into the effectiveness of these oral hygiene regimens.

Conditions

• Gingival Bleeding
• Plaque Induced Gingival Disease
• Gingivitis and Periodontal Diseases

Interventions

Type	Name	Description
DRUG	Mouthwash CPC+Zn+F	A mouthwash containing CPC + Zn and fluoride
DRUG	Essential oils mouthrinse	Essential oils mouthrinse
DEVICE	Dental floss	Dental floss
DRUG	Toothpaste	A commercially available fluoride toothpaste
DEVICE	Toothbrush	A commercially available adult toothbrush

Timeline

• Start date: 2024-09-16
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2024-09-23
• Last updated: 2025-04-14

Locations

1 site across 1 country: Brazil