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

Launched by COLGATE PALMOLIVE · Dec 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special toothpaste that contains 0.3% chlorhexidine, aimed at people who have dental plaque and gingivitis, which is gum inflammation. The study will involve 80 participants aged between 18 and 70 years. It will last for 21 days and is designed to see how well this toothpaste works in improving gum health and reducing plaque.

To be eligible for the trial, participants should be in good overall health and have at least 20 natural teeth. They must also have signs of gingivitis, such as bleeding gums, and be available for the entire study period. Participants will be randomly assigned to either use the special toothpaste or a placebo (a toothpaste without active ingredients) without knowing which one they have. Throughout the study, participants will receive guidance and support from the research team, ensuring a safe and informative experience. This trial is currently recruiting, so interested individuals should consider discussing it with their dentist or healthcare provider.

Gender

ALL

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.