Remineralizing effect of a highly fluoridated toothpaste, a fluoride gel and a fluoride varnish in situ
- Conditions
- K02Dental caries
- Registration Number
- DRKS00022321
- Lead Sponsor
- niversität BernKlinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
• give written informed consent;
• be between the ages of 18 and 70;
• be in good general health;
• agree not to participate in any other clinical study for the duration of this study;
• agree to refrain from using any non-study oral hygiene products including: toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration other than their usual toothbrush and toothpaste which will be used during the Acclimation period between each visit;
• have a minimum of 20 teeth (excluding third molars);
• agree to return for the scheduled clinical visits and follow study procedures
• active participation in another oral/dental products clinical study;
• current severe chronic illness or infectious disease;
• drug or alcohol abuse;
• eating disorders,
• pregnancy or breast feeding;
• antibiotic use (2 months before and during study) or medication reducing salivary flow;
• intake of other medications that might have an impact on the outcome;
• bad oral cleanliness, no agreement to comply with study design;
• known allergic reactions to any of the test substances;
• other allergic reactions to dental materials or oral hygiene products
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At the participant level, the primary endpoint is reached after 20 weeks (final examination and delivery of the fourth phase appliance, nutritional protocol, products and toothbrush).<br><br>At the specimen level, the primary endpoint is reached after the evaluation of the mineral content and the lesion depth of the specmines and after evaluation of the biofilm on the samples.
- Secondary Outcome Measures
Name Time Method