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Clinical trial of fluoride varnish in preventing dental caries of Sjögren’s syndrome patients

A randomized, double-blind, placebo-controlled clinical trial of fluoride varnish in preventing dental caries of Sjögren’s syndrome patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85164658
Enrollment
120
Registered
2016-09-09
Start date
2009-06-11
Completion date
Unknown
Last updated
2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries development in Sjögren’s syndrome patients Oral Health

Interventions

Sjögren’s syndrome patients were randomly assigned to receive either professionally applied fluoride varnish or placebo gel quarterly. Development and arrest of caries at the coronal and root surfaces

Sponsors

Research Grants Council of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Caries at the coronal and root surface evaluated using the International Caries Detection and Assessment System (ICDAS) at 12 months and 24 months

Secondary

MeasureTime frame
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

Countries

Hong Kong

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026