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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01446107
First received: September 23, 2011
Last updated: October 4, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Dental Caries
Other: placement of fissure sealant
Other: fluoride varnish
Other: silver fluoride
Other: placebo control
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • dental caries [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    tooth decay appearing as a cavity on tooth surface


Enrollment: 502
Study Start Date: December 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446107

Locations
China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Edward CM Lo, PhD The University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01446107     History of Changes
Other Study ID Numbers: UW06-402T/1427
Study First Received: September 23, 2011
Last Updated: October 4, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
tooth decay
fluoride
sealant
prevention

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014