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

NCT06732466 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-08-06

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Federal University of Rio Grande do Sul

    collaborator OTHER

  • Colgate Palmolive

    lead INDUSTRY

Principal Investigators

  • Cassiano K Rosing, PhD · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2025-04-15
Completion
2025-04-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06732466 on ClinicalTrials.gov