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

Phase 2

Completed

• Conditions: Dental Caries
• Interventions: Other: Resin dental sealant; Other: ART dental sealant; Other: Silver fluoride solution; Other: Sodium fluoride varnish

• Registration Number: NCT01829334
• Lead Sponsor: The University of Hong Kong

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:

1. 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,

2. to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and

3. to compare the cost-effectiveness of the above four caries prevention methods.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2013-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-08
• Last Update Submitted: 2013-04-08
• Study First Posted: 2013-04-11
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resin dental sealant	Resin dental sealant	Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
ART dental sealant	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
Silver fluoride solution	Silver fluoride solution	Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
Sodium fluoride varnish	Sodium fluoride varnish	Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months

Primary Outcome Measures

Name	Time	Method
dental caries	3 years	development of carious cavity after 3 years

Trial Locations

Locations (1)

Primary schools; 🇨🇳 Shenzhen, China