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

NCT06732466 | Completed Phase 3 DMC

• 1 other identifier: CRO-2024-11-PG-CHX-BZ-CB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chlorhexidine; toothpastes; gingivitis; dental plaque

Outcome Measures

Primary Outcomes (1)

• Löe-Silness Gingival Index

  A Löe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored.

  21 days

Secondary Outcomes (2)

• Modified Quigley-Hein Plaque Index

  21 days

• Lobene Stain index

  21 days

Study Arms (2)

0.3% chlorhexidine toothpaste

EXPERIMENTAL

Test group assigned to use a 0.3% chlorhexidine + 3% AmCl toothpaste and brushing with a commercially available adult soft bristle toothbrush

Drug: Chlorhexidine toothpaste; Device: Toothbrush

Negative Control

PLACEBO COMPARATOR

Negative Control group assigned to use a placebo toothpaste without chlorhexidine and AmCl and brushing with a commercially available adult soft bristle toothbrush

Device: Toothbrush; Drug: Placebo toothpaste without chlorhexidine and AmCl

Interventions

Chlorhexidine toothpaste DRUG

A toothpaste containing 0.3% chlorhexidine + 3% AmCl

0.3% chlorhexidine toothpaste

Toothbrush DEVICE

Commercially available adult soft bristle toothbrush

0.3% chlorhexidine toothpaste; Negative Control

Placebo toothpaste without chlorhexidine and AmCl DRUG

Negative Control Group assigned to use a placebo toothpaste without chlorhexidine and AmCl and brushing with a commercially available adult soft bristle toothbrush.

Negative Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, between 18-70 years of age;
• Availability for the duration of the study;
• Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
• Willingness to provide information related to their medical history;
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);
• Initial gingivitis index a minimum average score of 1.5 as determined by the use of the Löe and Silness Gingival Index;
• More than 30% of bleeding sites and absence of periodontal disease;
• Informed Consent Form signed.

You may not qualify if:

• Absence of visible clinical signs of periodontal disease, such as the presence of suppuration, dental mobility, and/or extensive attachment loss;
• That received dental prophylaxis within 1 month prior to the Baseline visit;
• Oral pathology or a history of allergy to testing products;
• Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner;
• Subject participating in any other clinical study;
• Subject pregnant or breastfeeding;
• Subject allergic to oral care products, personal care consumer products, or their ingredients;
• Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
• Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
• Current smokers and subjects with a history of alcohol or drug abuse;
• Subjects with orthodontic appliances or presence of fixed or removable prosthodontics dentures that may interfere with the evaluations
• An existing medical condition (eg: diabetic people) which prohibits eating or drinking for periods up to 4 hours.

Sponsors & Collaborators

• Colgate Palmolive: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases; Gingival Diseases; Dental Plaque

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Infections; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Cassiano K Rosing, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In this clinical trial, masking involves several key roles to ensure unbiased results. The participant and the investigator are masked in this double-blind study. This means that the participants do not know which group they have been assigned to and the investigators conducting the study do not know the group assignments. This comprehensive masking approach is designed to minimize any potential biases and maintain the integrity of the study results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase III, one-center, parallel group, double blind and randomized trial

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: March 24, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)