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

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dental Plaque; Gingival Disease; Gingivitis and Periodontal Diseases; Gingivitis

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06732466

CRO-2024-11-PG-CHX-BZ-CB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups, including a placebo group

0.3% chlorhexidine toothpaste

Experimental group

Description:

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

Treatment:

Device: Toothbrush

Drug: Chlorhexidine toothpaste

Negative Control

Placebo Comparator group

Description:

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

Treatment:

Device: Toothbrush

Drug: Placebo toothpaste without chlorhexidine and AmCl