|- candidate number||5419|
|- NTR Number||NTR1699|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-mrt-2009|
|- Secondary IDs||08CDP011 |
|- Public Title||Which dental treatment is the best for children in Brasil.|
|- Scientific Title||Cost-effectiveness of basic oral care approaches in caries active children in Brasil.|
|- hypothesis||The 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) studied||Dental caries|
|- Inclusion criteria||1. Healthy children;|
2. Complete primary molars dentition and at least two molars with cavities;
3. Informed consent received.
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-mrt-2009|
|- planned closingdate||1-apr-2015|
|- Target number of participants||600|
|- Interventions||1. Plaque control through tooth brushing;|
2. Restorations in cavitated primary molars
sealants in caries active 1st permanent molars.
|- Primary outcome||1. 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 outcome||1. 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.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Ass. Prof. Soraya Leal|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.E. Frencken|
|- Sponsor/Initiator ||Local dental authority (Brasilia)|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen, Local dental authority (Brasilia), University of Brasilia|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||13-mrt-2009 - 14-sep-2009|