A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 329
- Locations
- 1
- Primary Endpoint
- dental caries
Study Overview
Brief Summary
The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China.
The four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.
The specific study objectives are:
- to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,
- to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
- to compare the cost-effectiveness of the above four caries prevention methods.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •school children in good general health
- •has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries
Exclusion Criteria
- •children with major systemic disease or on long-term medication
- •children not cooperative and refuse dental treatments
Arms & Interventions
Resin dental sealant
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
Intervention: Resin dental sealant (Other)
ART dental sealant
ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
Intervention: ART dental sealant (Other)
Sodium fluoride varnish
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
Intervention: Sodium fluoride varnish (Other)
Silver fluoride solution
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
Intervention: Silver fluoride solution (Other)
Outcomes
Primary Outcomes
dental caries
Time Frame: 3 years
development of carious cavity after 3 years
Secondary Outcomes
No secondary outcomes reported
Investigators
LO, Edward Chin Man
Professor
The University of Hong Kong