Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
1 other identifier
interventional
502
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedMay 3, 2021
September 1, 2011
3 years
September 23, 2011
April 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
dental caries
tooth decay appearing as a cavity on tooth surface
3 years
Study Arms (4)
fissure sealant
EXPERIMENTALsingle placement of resin fissure sealant on tooth surface
fluoride varnish
EXPERIMENTALapplication of a 5% sodium fluoride varnish every 6 months
SDF solution
EXPERIMENTALapplication of a 38% silver diamine fluoride solution onto tooth surface every year
control
PLACEBO COMPARATORapplication of water onto tooth surface every year
Interventions
placement of resin-based fissure sealant at baseline without replacement
topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months
topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- children with major systemic disease or taking long-term medications
- not cooperative or refuse dental treatments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong
Hong Kong, China
Related Publications (1)
Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
PMID: 22736448DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward CM Lo, PhD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2011
First Posted
October 5, 2011
Study Start
December 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
May 3, 2021
Record last verified: 2011-09