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NCT Number: NCT01446107

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

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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Key information

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

placement of fissure sealant

Other

placement of resin-based fissure sealant at baseline without replacement

fluoride varnish

Other

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

Silver Fluoride

Other

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

Placebo control

Other

application of water onto tooth surface every year

Primary outcomes

  1. dental caries

    Time frame: 3 years

    tooth decay appearing as a cavity on tooth surface

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 5, 2011
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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