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

NCT01446107 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2021-05-03

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

OTHER

placement of fissure sealant

placement of resin-based fissure sealant at baseline without replacement

OTHER

fluoride varnish

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

OTHER

silver fluoride

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

OTHER

placebo control

application of water onto tooth surface every year

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Edward CM Lo, PhD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446107 on ClinicalTrials.gov