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Trial record 48 of 1215 for:    tooth decay

Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth

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ClinicalTrials.gov Identifier: NCT01829334
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
LO, Edward Chin Man, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE April 8, 2013
First Posted Date  ICMJE April 11, 2013
Last Update Posted Date April 11, 2013
Study Start Date  ICMJE June 2006
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
dental caries [ Time Frame: 3 years ]
development of carious cavity after 3 years
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Official Title  ICMJE A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Brief Summary

The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China.

The four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.

The specific study objectives are:

  1. to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,
  2. to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
  3. to compare the cost-effectiveness of the above four caries prevention methods.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Other: ART dental sealant
    ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
  • Other: Resin dental sealant
    Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
  • Other: Sodium fluoride varnish
    Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
  • Other: Silver fluoride solution
    Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
Study Arms  ICMJE
  • Active Comparator: Resin dental sealant
    Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
    Intervention: Other: Resin dental sealant
  • Experimental: ART dental sealant
    ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
    Intervention: Other: ART dental sealant
  • Experimental: Sodium fluoride varnish
    Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
    Intervention: Other: Sodium fluoride varnish
  • Experimental: Silver fluoride solution
    Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
    Intervention: Other: Silver fluoride solution
Publications * Liu BY, Xiao Y, Chu CH, Lo EC. Glass ionomer ART sealant and fluoride-releasing resin sealant in fissure caries prevention--results from a randomized clinical trial. BMC Oral Health. 2014 May 19;14:54. doi: 10.1186/1472-6831-14-54.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2013)
329
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • school children in good general health
  • has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries

Exclusion Criteria:

  • children with major systemic disease or on long-term medication
  • children not cooperative and refuse dental treatments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01829334
Other Study ID Numbers  ICMJE UW 06-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LO, Edward Chin Man, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward CM Lo The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP