NCT06732466

Evaluation of the Effect of a Toothpaste Containing 0.3% Chlorhexidine in Subjects With Established Dental Plaque and Gingivitis

Clinical Research Study to Evaluate the Effect of a Toothpaste Containing Chlorhexidine 0.3% in Subjects With Established Dental Plaque and Gingivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, one-center, parallel group, double blind, clinical study to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It involves 80 participants aged between 18 and 70, randomly assigned to different groups, and spans 21 days.

Detailed description

This clinical study aims to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It is a Phase III study designed as randomized, one-center, double blind, parallel group trial involving 80 participants aged 18 to 70. Subjects will be divided into two groups: test group - subjects assigned to use a toothpaste with a 0.3% chlorhexidine + 3% AmCl and brush with a commercially available adult soft bristle toothbrush; negative control group - subjects assigned to use a placebo toothpaste without chlorhexidine and AmCl and brush with a commercially available adult soft bristle toothbrush. Subjects will undergo baseline, 14 days and 21 days evaluations. The primary outcome will be reduction of gingival inflammation and data will be analyzed using ANCOVA to assess the efficacy of the test product. 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 the chlorhexidine toothpaste regarding gingivitis and dental plaque control.

Conditions

• Gingivitis
• Gingivitis and Periodontal Diseases
• Gingival Disease
• Dental Plaque

Interventions

Type	Name	Description
DRUG	Chlorhexidine toothpaste	A toothpaste containing 0.3% chlorhexidine + 3% AmCl
DEVICE	Toothbrush	Commercially available adult soft bristle toothbrush
DRUG	Placebo toothpaste without chlorhexidine and AmCl	Negative Control Group assigned to use a placebo toothpaste without chlorhexidine and AmCl and brushing with a commercially available adult soft bristle toothbrush.

Timeline

• Start date: 2025-03-24
• Primary completion: 2025-04-15
• Completion: 2025-04-15
• First posted: 2024-12-13
• Last updated: 2025-08-06

Locations

1 site across 1 country: Brazil