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

NCT ID: NCT01829334

Last Updated: 2013-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

329 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-05-31

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:

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

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Resin dental sealant

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

Group Type ACTIVE_COMPARATOR

Resin dental sealant

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

ART dental sealant

Intervention Type OTHER

ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, 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

Group Type EXPERIMENTAL

Sodium fluoride varnish

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Silver fluoride solution

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Resin dental sealant

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

Intervention Type OTHER

Sodium fluoride varnish

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

Intervention Type OTHER

Silver fluoride solution

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

Intervention Type OTHER

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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LO, Edward Chin Man

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward CM Lo

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Primary schools

Shenzhen, , China

Site Status

Countries

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China

References

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Liu BY, Xiao Y, Chu CH, Lo EC. Glass ionomer ART sealant and fluoride-releasing resin sealant in fissure caries prevention--results from a randomized clinical trial. BMC Oral Health. 2014 May 19;14:54. doi: 10.1186/1472-6831-14-54.

Reference Type DERIVED
PMID: 24886444 (View on PubMed)

Other Identifiers

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UW 06-203

Identifier Type: -

Identifier Source: org_study_id

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