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

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ART dental sealant
Resin dental sealant
Sodium fluoride varnish
Silver fluoride solution
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring dental caries

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Primary schools

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Resin dental sealant

ART dental sealant

Sodium fluoride varnish

Silver fluoride solution

Arm Description

Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement

ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement

Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months

Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months

Outcomes

Primary Outcome Measures

dental caries
development of carious cavity after 3 years

Secondary Outcome Measures

Full Information

First Posted
April 8, 2013
Last Updated
April 8, 2013
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01829334
Brief Title
Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Official Title
A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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, to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and to compare the cost-effectiveness of the above four caries prevention methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
329 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resin dental sealant
Arm Type
Active Comparator
Arm Description
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
Arm Title
ART dental sealant
Arm Type
Experimental
Arm Description
ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
Arm Title
Sodium fluoride varnish
Arm Type
Experimental
Arm Description
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
Arm Title
Silver fluoride solution
Arm Type
Experimental
Arm Description
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
Intervention Type
Other
Intervention Name(s)
ART dental sealant
Intervention Description
ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
Intervention Type
Other
Intervention Name(s)
Resin dental sealant
Intervention Description
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
Intervention Type
Other
Intervention Name(s)
Sodium fluoride varnish
Intervention Description
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
Intervention Type
Other
Intervention Name(s)
Silver fluoride solution
Intervention Description
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
Primary Outcome Measure Information:
Title
dental caries
Description
development of carious cavity after 3 years
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward CM Lo
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary schools
City
Shenzhen
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24886444
Citation
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.
Results Reference
derived

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

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