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Which dental treatment is the best for children in Brasil.


- candidate number5419
- NTR NumberNTR1699
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2009
- Secondary IDs08CDP011 
- Public TitleWhich dental treatment is the best for children in Brasil.
- Scientific TitleCost-effectiveness of basic oral care approaches in caries active children in Brasil.
- ACRONYMN/A
- hypothesisThe prevalence and severity of dental caries among primary-school going children is high. Many tooth cavities are not treated. This is due to the high cost and cumberness of the electrical driven dental equipment. A new treatment approach has been developed, thouroughly tested, that uses hand instruments only and which is considered cheaper than the traditional approach (ART). ART also includes prevention of carious lesions through the use of hand instruments only. Null-hypotheses:
1. There is no difference in carious lesion prevention in 1st permanent molars between those sealed and those under plaque control only;
2. There is no difference in exfoliation of cavitated primary molars between those restored and those under plaque control;
3. There is no difference in dental anxiety between children that have been treated restoratively and those who are not;
4. There is no difference in pain experience between children that have been treated restoratively and those who are not;
5. There is no difference in cost-effectiveness between children that have been treated according to the traditional approach and those treated according to two minimal intervention approaches.
- Healt Condition(s) or Problem(s) studiedDental caries
- Inclusion criteria1. Healthy children;
2. Complete primary molars dentition and at least two molars with cavities;
3. Informed consent received.
- Exclusion criteria1. No informed consent received;
2. Children that have already molar teeth extracted, have molars with symptoms and those that have less than two molars cavitated.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-mrt-2009
- planned closingdate1-apr-2015
- Target number of participants600
- Interventions1. Plaque control through tooth brushing;
2. Restorations in cavitated primary molars sealants in caries active 1st permanent molars.
- Primary outcome1. Number of symptom-free naturally exfoliated primary molars;
2. Survival of restored teeth;
3. Survival of caries-free pits and fissures in 1st permanent molars;
4. Cost-effectiveness of the three treatment approaches.
- Secondary outcome1. Prevalence of oral health indices over time;
2. Dental anxiety by treatment group;
3. Pain experience by treatment group;
4. Quality-of-life over time;
5. Impact of oral health promotion.
- TimepointsAnnual.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESAss. Prof. Soraya Leal
- CONTACT for SCIENTIFIC QUERIESDr. J.E. Frencken
- Sponsor/Initiator Local dental authority (Brasilia)
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen, Local dental authority (Brasilia), University of Brasilia
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD13-mrt-2009 - 14-sep-2009


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