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Glass-ionomer-based materials for preventing carious lesions in Chinese children


- candidate number3959
- NTR NumberNTR1441
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2008
- Secondary IDs08CDP011 
- Public TitleGlass-ionomer-based materials for preventing carious lesions in Chinese children
- Scientific TitleCost-effectiveness of glass-ionomer sealants in grade 2 children in Wuhan, China after 5 years
- ACRONYMN/A
- hypothesisThere is no difference in carious lesion development between sealants of glass-ionomer, glass-carbomer and composite resin and placed in first permanent molars after 5 years
- Healt Condition(s) or Problem(s) studiedCaries, Prevention, Children
- Inclusion criteria1. Healthy children with at least 2 cavitated teeth in primary dentition and patent pits and fissures or presence of enamel carious lesion in first permanent molar (high caries risk group)
- Exclusion criteria1. Healthy children with less than 2 cavitated teeth in their primary dentition, and those with two or more cavitated primary teeth but with shallow pits and fissures in the first permanent molars.
2. Permanent molars with cavities
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-apr-2008
- planned closingdate30-jun-2013
- Target number of participants400
- InterventionsFour sealant groups.
1. Composite resin = positive control
2. Glass-ionomer, improved version = experimental
3. Glass-ionomer plus light-curing = experimental
4. Glass-carbomer, new material = experimental
First permanent molars will be sealed.
- Primary outcome- Prevention of carious lesions in first permanent molars
- Secondary outcome1. Retention of the sealants
2. Costing of sealant application
3. Attrition pattern of sealants over time
4. Composition of sealants over time
- TimepointsClinical evaluation after 6 months, 1, 2, 3, 4, and 5 years.
Each time of evaluation an impression of a sample of sealed teeth by group will be taken.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. J.E. Frencken
- CONTACT for SCIENTIFIC QUERIESDr. J.E. Frencken
- Sponsor/Initiator Radboud University Medical Centre, College of Dental Sciences
- Funding
(Source(s) of Monetary or Material Support)
School of Stomatology, Wuhan, China., Koninklijke Nederlandse Akademie van Wetenschappen (KNAW), College of Dental Sciences, the Netherlands
- PublicationsN/A
- Brief summaryThe study inclusion criteria consist of molar teeth in the mandible that are at high risk for developing carious lesions in pits and fissures of occlusal and buccal tooth surfaces of young children. The number of children included in the study have been determined through power calculations and randomly divided over 3 parallel groups: a resin, a high-viscosity glass-ionomer and a glass-carbomer sealant group. The different sealant materials have been applied using the manufacturers’ Direction for Use.
Sealants will be periodically (0.5, 1, 2, 3, 4 and 5 years) evaluated by independent and calibrated evaluators using the ART criteria.
The wear pattern over time will be assessed from replicas produced from impressions taken at each of the 6 evaluation times. The measurements will include loss of volume and height obtained through using 3-D laser images and relevant computer software. Survival analysis and parametric tests will be applied to assess the type of sealant that prevents carious lesion development in pits and fissures of these children best. Cost data have been collected using activity sampling procedure.
- Main changes (audit trail)
- RECORD10-sep-2008 - 18-sep-2008


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