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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446107
• Other study ID #: UW06-402T/1427
• Status: Completed
• Phase: N/A
• Start date: December 2007
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

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

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dental caries	tooth decay appearing as a cavity on tooth surface	3 years