Status:
COMPLETED
Comparative Study to Evaluate the Efficacy of an Alcohol-free Mouthwash Regimen With CPC+Zn, Flossing and Brushing, and an Alcohol-based Mouthwash Regimen With Essential Oils in Reducing Plaque and Gingivitis.
Lead Sponsor:
Colgate Palmolive
Collaborating Sponsors:
Universidad Autonoma de San Luis Potosí
Conditions:
Gingival Bleeding
Plaque Induced Gingival Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a Phase III, randomized, one-center, parallel group, double blinded, clinical study to evaluate the efficacy of an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and t...
Detailed Description
This clinical study aims to evaluate the efficacy of a regimen including an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and brushing and to a regimen including a rinsing wi...
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; At least 20 teeth with scorable facial and lingual surfaces; evidence of gingivitis; At least 10 bleeding sites based on the Bleeding Index (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
- No sites with more than 5 mm probing depth, and a maximum of three sites of 5 mm probing depth.
- Have 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 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06598072
Start Date
September 17 2024
End Date
December 16 2024
Last Update
April 14 2025
Active Locations (1)
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1
Universidad Autónoma de San Luis Potosí
San Luis Potosí City, San Luis Potosí, Mexico, 78000