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van CCT (UK)


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van CCT (UK)


Hand instruments are better accepted than rotary instrumentation for restoring tooth cavities in people with disabilities.


- candidate number16059
- NTR NumberNTR4400
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jan-2014
- Secondary IDsR0000703 
- Public TitleHand instruments are better accepted than rotary instrumentation for restoring tooth cavities in people with disabilities.
- Scientific TitleThe suitability and effectiveness of the art approach for people with disabilities.
- ACRONYM
- hypothesisThe ART approach is more suitable than conventional restorative treatment in people with disabilities
- Healt Condition(s) or Problem(s) studiedCaries, Disability, General anesthesia, Atraumatic Restorative Treatment
- Inclusion criteriaPatients with a recognised disability and at least one dentinal carious laesion in a primary or permanent tooth without pulpal involvement, spontaneous pain or tooth mobility, but in occlusion with the antagonist tooth or teeth and in contact with the neighbouring tooth or teeth.
- Exclusion criteria-
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jul-2012
- planned closingdate2-feb-2016
- Target number of participants70
- InterventionsAtraumatic Restorative Treatment (ART) in the clinic; conventional restorative treatment (CRT) in the clinic and under general anaesthesia (GA)
- Primary outcomeSurvival of restorations
- Secondary outcome- Acceptance of treatment protocols - Suitability - Feasibiliy - Satisfaction of ART
- Timepoints0.5, 1,2,3 years
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. J.E. Frencken
- CONTACT for SCIENTIFIC QUERIESDr. J.E. Frencken
- Sponsor/Initiator Radboud University Nijmegen Medical Centre, Department of Global Oral Health, Secretaría de Ciencia y Tecnología, Universidad Nacional de Córdoba
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen, Secretaría de Ciencia y Tecnología, Universidad Nacional de Córdoba (Argentina)
- Publicationsn/a
- Brief summaryMany environmental barriers exist to the access of oral health care in the population with disability, but once these barriers have been overcome, and the patient has been able to find a dentist willing and able to treat them, challenges remain. The provision of high quality restorative treatment is related to the patient’s ability to cope with the anxiety engendered by treatment and to cooperate fully with the demands of the clinical situation. Between a quarter and a third of adults with intellectual disability are estimated to have dental anxiety. Unpleasant stimuli, such as the injection of local anaesthesia, or the noise and vibration of rotary instruments, may provoke disproportionate anxiety and subsequent opposition to treatment. In addition, poor muscle coordination, fatigability or oral dysfunction, such as drooling and tongue movement, may compromise restorative procedures. Sedation or general anaesthesia may improve clinical conditions for restorative work but these techniques have their own problems in terms of cost and patient morbidity. A less anxiety-provoking restorative treatment is Atraumatic Restorative Treatment (ART). This approach is endorsed by the World Health Organisation and involves hand instrumentation and placement of high-viscosity glass-ionomer cement restorations. ART has been shown to be equally effective as conventional restoration in both primary and permanent teeth. It has been suggested that ART might help to reduce barriers to treatment for patients with disabilities but no trial comparing ART with conventional treatment in this population has yet been reported. The present study aimed to compare ART with conventional restorative treatment in terms of respondent acceptance, satisfaction, feasibility of the approach and survival of the restorations over a three year period.
- Main changes (audit trail)
- RECORD15-jan-2014 - 2-apr-2014


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