|- candidate number||9037|
|- NTR Number||NTR2719|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-jan-2011|
|- Secondary IDs||08.10.51205 RvB Radboud University Nijmegen|
|- Public Title||The influence of a training programm for dentists in upper Egypt to use the ART (Atraumatic Restorative Technique) method for cleaning and filling tooth cavities, only using hand instruments.|
|- Scientific Title||Introduction of the ART technique in Upper Egypt: The influence of a special training program for general dental practitioners.|
|- hypothesis||The aim of this study is to assess the influence of a special training program on the introduction of a new technique for treating carious (cavitated) teeth with a simple method, specially developed for the health care system in low- and middle income countries. |
|- Healt Condition(s) or Problem(s) studied||Caries, Periodontal health, ART, Glass ionomer, Tooth cavities|
|- Inclusion criteria||General dental practicitioners (GDPs) in Upper Egypt:|
1. Interventiongroup: GDPs in El Minia city;
2. Control group: GDPs in Asuit.
|- Exclusion criteria||All other oral health care providers in Upper Egypt.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2011|
|- planned closingdate||1-apr-2012|
|- Target number of participants||60|
|- Interventions||Control group (n=30): Questionnaires on current knowledge and oral health care.|
Intervention group (n=30):
1. Training course (3 days): Lectures and discussions on caries prevention and caries management;
2. Skills training (2 days): Training in preparation and restoration of carious teeth using the ART technique, and glass ionomer cement as restoration material;
3. Reminder sessions: Discussion on perceived barriers using the ART technique.
|- Primary outcome||1. Change in GDPs knowledge on caries management;|
2. Change in frequencies of ART restorations in governmental and privat clinics.
For all assessments: Intervention group compared to control group; intervention group and control group compared to baseline data, and to each other.
Data will be collected using questionnaires among GDPs (change in knowledge), and registration forms in governmental and privat dental clinics (clinical data).
|- Secondary outcome||N/A|
|- Timepoints||1. Change in knowledge: Directly post training, and after another 12 months;|
2. Change in clinical performance: After 3, 6, and 12 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Wil J.M. Sanden, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Wil J.M. Sanden, van der|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre, Department of Global Oral Health|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Publications||Pre-study publications:|
Farag A, van der Sanden WJ, Abdelwahab H, Frencken JE. Survival of ART restorations assessed using selected FDI and modified ART restoration criteria. Clin Oral Invest 2010;
Farag A, van der Sanden WJ, Abdelwahab H, Mulder J, Frencken JE. 5-Year survival of ART restorations with and without cavity disinfection. J Dent 2009;37:468-74
|- Brief summary||The ART (Atraumatic Restorative Technique) approach involves opening the toothcavity with dental hatchets, removing soft carious tooth tissues with small and large excavators and filling the cavity and the adjacent pits and fissures with a handmixed or encapsulated glass ionomer.
General dental practitioners (GDPs) in many countries, including Egypt, have difficulty in accepting the modern concept of minimal intervention dentistry.|
The acceptance and feasibility of the ART approach for integration in the Egyption oral health care system will be tested in this study.
A randomised controlled trial in 2 remote areas in Upper Egypte. All GDPs in these areas will be asked to participate.
1. Lectures on modern caries management approaches;
2. Skills training on tooth preparation and restoration using the the ART approach.
Pretest and posttest assessments using questionnaires, to test the influence on GDPs' knowledge.
Clinical recording forms to test the change in the frequency of ART restorations.
|- Main changes (audit trail)|
|- RECORD||27-jan-2011 - 8-feb-2011|