Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries

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

NA

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-12-31

Brief Summary

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Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.

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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

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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fissure sealant

single placement of resin fissure sealant on tooth surface

Group Type EXPERIMENTAL

placement of fissure sealant

Intervention Type OTHER

placement of resin-based fissure sealant at baseline without replacement

fluoride varnish

application of a 5% sodium fluoride varnish every 6 months

Group Type EXPERIMENTAL

fluoride varnish

Intervention Type OTHER

topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months

SDF solution

application of a 38% silver diamine fluoride solution onto tooth surface every year

Group Type EXPERIMENTAL

silver fluoride

Intervention Type OTHER

topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year

control

application of water onto tooth surface every year

Group Type PLACEBO_COMPARATOR

placebo control

Intervention Type OTHER

application of water onto tooth surface every year

Interventions

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placement of fissure sealant

placement of resin-based fissure sealant at baseline without replacement

Intervention Type OTHER

fluoride varnish

topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months

Intervention Type OTHER

silver fluoride

topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year

Intervention Type OTHER

placebo control

application of water onto tooth surface every year

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* school children in good general health
* have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries