Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
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ClinicalTrials.gov Identifier: NCT01829334 |
Recruitment Status :
Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dental Caries | Other: ART dental sealant Other: Resin dental sealant Other: Sodium fluoride varnish Other: Silver fluoride solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 329 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Resin dental sealant
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
|
Other: Resin dental sealant
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement |
Experimental: 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
|
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 |
Experimental: Sodium fluoride varnish
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
|
Other: Sodium fluoride varnish
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months |
Experimental: Silver fluoride solution
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
|
Other: Silver fluoride solution
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months |
- dental caries [ Time Frame: 3 years ]development of carious cavity after 3 years

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Ages Eligible for Study: | 6 Years to 9 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829334
China | |
Primary schools | |
Shenzhen, China |
Principal Investigator: | Edward CM Lo | The University of Hong Kong |
Responsible Party: | LO, Edward Chin Man, Professor, The University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT01829334 |
Other Study ID Numbers: |
UW 06-203 |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | April 11, 2013 |
Last Verified: | April 2013 |
dental caries |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Listerine Fluorides Sodium Fluoride |
Fluorides, Topical Cariostatic Agents Protective Agents Physiological Effects of Drugs Anti-Infective Agents, Local Anti-Infective Agents |