Evaluation of the Effect of a Toothpaste Containing 0.3% Chlorhexidine in Subjects With Establish… (NCT06732466) | Clinical Trial Compass
CompletedPhase 3
Evaluation of the Effect of a Toothpaste Containing 0.3% Chlorhexidine in Subjects With Established Dental Plaque and Gingivitis
Brazil80 participantsStarted 2025-03-24
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 produc…