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van CCT (UK)


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van CCT (UK)


Is it effective and cost-effective to seal dental caries instead of "drilling and filling"?


- candidate number27581
- NTR NumberNTR6580
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jul-2017
- Secondary IDs843001810 ZonMw, 's Gravenhage
- Public TitleIs it effective and cost-effective to seal dental caries instead of "drilling and filling"?
- Scientific TitleSealing occlusal dental caries (ICDAS 3/4) instead of "care as usual" consisting of preparation and restoration of the dental caries lesion: effectiveness, cost-effectiveness and impact on children's quality of life
- ACRONYM
- hypothesisDental caries lesions (with ICDAS Codes 3 and 4) can be treated by sealing, offering a less invasive and less costly treatment option with the same results as preparation and restoration of the carious lesions.
- Healt Condition(s) or Problem(s) studiedDental caries, Caries
- Inclusion criteriaAge 3-18 years
Caries lesions in occlusal surface
Lesion stage ICDAS 3 and 4
- Exclusion criteriaUnder 3 years / over 17 years
Caries lesions in other surfaces
Lesion stage ICDAS 0, 1, 2, 5 and 6
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-dec-2017
- planned closingdate15-dec-2020
- Target number of participants480
- InterventionsIntervention group:
cleaning occlusal surface with rotating brush pumice, isolation of tooth (rubberdam), placement of resin-based sealant after etching

Control group (care as usual)
local anesthetic, isolation (rubberdam), preparation / excavation with rotating instruments, restoration with composite resin or compomer restoration material.
- Primary outcome- first-attempt success rate
- Secondary outcome- caries progression after two years
- cost-effectiveness from both a medical and societal perspective
- differences in QALYs (CHU-9D)
- differences in dental fear (CFFS-DS)
- TimepointsT=0: start of intervention
T=1: control after 12 months
T=2: end of the trial
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES J.H. Vermaire
- CONTACT for SCIENTIFIC QUERIES J.H. Vermaire
- Sponsor/Initiator University Medical Centre Groningen (UMCG), Centre for Dentistry and Oral Hygiene
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryThe past 5 years, there is gaining evidence that occlusal dental caries can be inhibited or stopped by sealing the lesion rather than removing all carious tissue and placing a restoration.

This study aims to assess the effectiveness and cost-effectiveness of sealing occlusal ICDAS 3 and 4 lesions by comparing the sealing method with care as usual (placing a restoration).
- Main changes (audit trail)
- RECORD24-jul-2017 - 12-aug-2017


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