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NCT01829334 Clinical Trial

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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01829334
Other study ID # UW 06-203
Secondary ID
Status Completed
Phase Phase 2
First received April 8, 2013
Last updated April 8, 2013
Start date June 2006
Est. completion date May 2009

Study information
Verified date April 2013
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 329
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 9 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Primary schools Shenzhen

Sponsors (1)
Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary dental caries development of carious cavity after 3 years 3 years No
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