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Completed

NCT Number: NCT01829334

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Primary schools

Shenzhen, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ART dental sealant

Other

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

Other

Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement

Sodium fluoride varnish

Other

Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months

Silver fluoride solution

Other

Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months

Primary outcomes

  1. dental caries

    Time frame: 3 years

    development of carious cavity after 3 years

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 11, 2013
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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