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

Study Overview
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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.

Official Title
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A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries

Conditions
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Dental Caries

Intervention / Treatment
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* Other: placement of fissure sealant
* Other: fluoride varnish
* Other: silver fluoride
* Other: placebo control


Participation Criteria
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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 Exclusion Criteria: children with major systemic disease or taking long-term medications not cooperative or refuse dental treatments

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fissure sealant<br>single placement of resin fissure sealant on tooth surface | Other: placement of fissure sealant<br>* placement of resin-based fissure sealant at baseline without replacement<br>|
| Experimental: fluoride varnish<br>application of a 5% sodium fluoride varnish every 6 months | Other: fluoride varnish<br>* topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months<br>|
| Experimental: SDF solution<br>application of a 38% silver diamine fluoride solution onto tooth surface every year | Other: silver fluoride<br>* topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year<br>|
| Placebo Comparator: control<br>application of water onto tooth surface every year | Other: placebo control<br>* application of water onto tooth surface every year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dental caries | tooth decay appearing as a cavity on tooth surface | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tooth decay, fluoride, sealant, prevention