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

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT01446107

Collaborator

(none)

502

Enrollment

Location

Arms

Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Other: placement of fissure sealant Other: fluoride varnish Other: silver fluoride Other: placebo control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

502 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

dental caries [3 years]
tooth decay appearing as a cavity on tooth surface

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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