Evaluating a chlorhexidine toothpaste for 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

This study is testing a new toothpaste with chlorhexidine to see if it can help adults aged 18 to 70 reduce dental plaque and gingivitis.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Colgate Palmolive (industry)
• Locations: 1 site (Porto Alegre, RS)
• Trial ID: NCT06732466 on ClinicalTrials.gov

What this trial studies

This clinical study assesses the effectiveness of a toothpaste containing 0.3% chlorhexidine in reducing dental plaque and gingivitis in adults aged 18 to 70. It is a Phase III, randomized, double-blind, parallel group trial involving 80 participants who will be assigned to either the chlorhexidine toothpaste or a placebo toothpaste. Evaluations will occur at baseline, 14 days, and 21 days to measure changes in gingival inflammation. The study aims to provide robust data on the efficacy of the chlorhexidine toothpaste in managing gingivitis and dental plaque.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 70 with established gingivitis and at least 20 natural teeth.

Not a fit: Patients without visible signs of periodontal disease or those who have received dental prophylaxis within the last month may not benefit from this study.

Why it matters

Potential benefit: If successful, this toothpaste could significantly improve oral health by effectively reducing gingivitis and dental plaque.

How similar studies have performed: Previous studies have shown positive outcomes with chlorhexidine in oral care, suggesting this approach is promising.

Eligibility criteria

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.

Where this trial is running

Porto Alegre, RS

• Federal University of Rio Grande do Sul — Porto Alegre, RS, Brazil (RECRUITING)

Study contacts

• Principal investigator: Cassiano K Rosing, PhD — Federal University of Rio Grande do Sul
• Study coordinator: Cassiano K Rosing, PhD

Conditions: Gingivitis, Gingivitis and Periodontal Diseases, Gingival Disease, Dental Plaque, chlorhexidine, toothpastes, gingivitis, dental plaque