Status:
COMPLETED
Comparative Study of CPC+Zn Mouthwash, Dental Floss, and Essential Oils Mouthwash on Plaque and Gingivitis Reduction
Lead Sponsor:
Colgate Palmolive
Collaborating Sponsors:
Federal University of Rio Grande do Sul
Conditions:
Gingival Bleeding
Plaque Induced Gingival Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This clinical study aims to evaluate the efficacy of an alcohol-free mouthwash containing CPC (Cetylpyridinium Chloride) and Zinc (Zn) in reducing dental plaque and gingivitis compared to dental floss...
Eligibility Criteria
Inclusion
- 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
- 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 course of the study;
- Subject participating in any other clinical study;
- Subject pregnant or breastfeeding;
- Subject allergic to oral care products, personal care consumer products, or their ingredients;
- Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
- Periodontal treatment 12 months before the beginning of the study;
- 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
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06607263
Start Date
September 16 2024
End Date
December 9 2024
Last Update
April 14 2025
Active Locations (1)
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1
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90010-150