Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Status and phase
Completed
Phase 2
Conditions
Dental Caries
Treatments
Other: Silver fluoride solution
Other: ART dental sealant
Other: Resin dental sealant
Other: Sodium fluoride varnish
Details and patient eligibility
About
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.
Enrollment
329 patients
Sex
All
Ages
6 to 9 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
329 participants in 4 patient groups
Resin dental sealant
Active Comparator group
Description:
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
Treatment:
Other: Resin dental sealant
ART dental sealant
Experimental group
Description:
ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
Treatment:
Other: ART dental sealant
Sodium fluoride varnish
Experimental group
Description:
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
Treatment:
Other: Sodium fluoride varnish
Silver fluoride solution
Experimental group
Description:
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
Treatment:
Other: Silver fluoride solution
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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