Clinical trial of fluoride varnish in preventing dental caries of Sjögren’s syndrome patients
Completed
- Conditions
- Caries development in Sjögren’s syndrome patientsOral Health
- Registration Number
- ISRCTN85164658
- Lead Sponsor
- Research Grants Council of Hong Kong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1. Clinical diagnosis of Sjögren’s syndrome established using the American-European Consensus Group (AECG) criteria at least 6 months before the commencement of this study
2. Age 18 or above
3. Had 8 or more natural teeth present
Exclusion Criteria
1. Severe periodontal disease (e.g., periodontal pockets were deeper than 6 mm) at two or more sextants
2. Received therapeutic irradiation to the head and neck region
3. Had concurrent systemic illness (except connective tissue disorder associated with secondary Sjögren’s syndrome)
4. Taking medication that altered salivary flow
5. Had participated in a clinical trial within 6 months before commencement of this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Caries at the coronal and root surface evaluated using the International Caries Detection and Assessment System (ICDAS) at 12 months and 24 months
- Secondary Outcome Measures
Name Time Method Counts of lactobacilli and Candida (expressed as colony forming units per milliliter (CFU/ml) in salivary samples and colony forming units per gram in dental plaque samples) evaluated at 12 months and 24 months