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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Dental Caries

Treatments: Other: fluoride varnish; Other: placebo control; Other: silver fluoride; Other: placement of fissure sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT01446107

UW06-402T/1427

Details and patient eligibility

About

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.

Enrollment: 502 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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502 participants in 4 patient groups, including a placebo group

fissure sealant

Experimental group

Description:

single placement of resin fissure sealant on tooth surface

Treatment:

Other: placement of fissure sealant

fluoride varnish

Experimental group

Description:

application of a 5% sodium fluoride varnish every 6 months

Treatment:

Other: fluoride varnish

SDF solution

Experimental group

Description:

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

Treatment:

Other: silver fluoride

control

Placebo Comparator group

Description:

application of water onto tooth surface every year

Treatment:

Other: placebo control