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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: ART dental sealant Other: Resin dental sealant Other: Sodium fluoride varnish Other: Silver fluoride solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Study Start Date : June 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
Drug Information available for: Fluoride

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Resin dental sealant
Resin dental sealant placed on pits and fissures of first permanent molars, 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
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
 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
Experimental: Sodium fluoride varnish
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
 Other: Sodium fluoride varnish
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
Experimental: Silver fluoride solution
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
 Other: Silver fluoride solution
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months


Outcome Measures
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Primary Outcome Measures :
  1. dental caries [ Time Frame: 3 years ]
    development of carious cavity after 3 years


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829334


Locations
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China
Primary schools
Shenzhen, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Edward CM Lo The University of Hong Kong
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LO, Edward Chin Man, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01829334     History of Changes
Other Study ID Numbers: UW 06-203
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by LO, Edward Chin Man, The University of Hong Kong:
dental caries

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Fluorides
Sodium Fluoride
 Fluorides, Topical
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents