Comparative Study of CPC+Zn Mouthwash, Dental Floss, and Essential Oils Mouthwash on Plaque and G… (NCT06607263) | Clinical Trial Compass
CompletedPhase 3
Comparative Study of CPC+Zn Mouthwash, Dental Floss, and Essential Oils Mouthwash on Plaque and Gingivitis Reduction
Brazil120 participantsStarted 2024-09-16
Plain-language summary
Clinical study evaluating the effectiveness of an alcohol-free mouthwash containing CPC+Zn compared to dental flossing and an essential oils-containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, single-center, double-blind trial with a parallel design. It involves 120 participants aged between 18 and 65, randomized into different groups, and spans 12 weeks.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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;
* ≥20 teeth with scorable facial and lingual surfaces; evidence of gingivitis;
* ≥10 bleeding sites based on the BI
* Initial mean gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index (MGI).
* Subjects without allergies to the products that are being tested;
* Informed Consent Form signed.
Exclusion Criteria:
* That received dental prophylaxis within 1 month prior to the Baseline visit;
* Need for antibiotics prior to dental treatment; use of antibiotics, anti-inflammatory or anticoagulant therapy during the three months prior to entry into the study;
* Usage of oral care products containing chemotherapeutic products within 2 weeks prior to Baseline;
* Use of smokeless tobacco;
* Any other condition that would make the volunteer inappropriate for the study.
* Oral pathology, chronic disease, 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 cours…