Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth

Conditions
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Dental Caries

Intervention / Treatment
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* Other: ART dental sealant
* Other: Resin dental sealant
* Other: Sodium fluoride varnish
* Other: Silver fluoride solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resin dental sealant<br>Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement | Other: Resin dental sealant<br>* Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement<br>|
| Experimental: ART dental sealant<br>ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement | Other: ART dental sealant<br>* ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement<br>|
| Experimental: Sodium fluoride varnish<br>Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months | Other: Sodium fluoride varnish<br>* Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months<br>|
| Experimental: Silver fluoride solution<br>Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months | Other: Silver fluoride solution<br>* Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dental caries | development of carious cavity after 3 years | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental caries