Dental Caries Clinical Trial
Official title:
Effectiveness of Modified Class IV Atraumatic Restorative Treatment - Results After 12 Months
Atraumatic Restorative Treatment (ART) has become an accepted dental restoration treatment in many developing countries. Because, ART is intended to be operated in molars, and about 10% of all carious lesion by an age of 18 years appear in anterior teeth in Gambia, it was the aim of this study to clinically evaluate a modified ART restoration technique for anterior teeth as the traditional treatment approach did not show satisfying clinical results.
Atraumatic Restorative Treatment (ART) has become an evidence-based treatment in class I
caries cavities for countries with developing dental infrastructure. Though epidemiological
data also demonstrate restorative treatment needs in anterior teeth in several African
countries, scientific evidence for ART in this application appeared so far unrewarding.
Consequently, many carious teeth remain untreated or are scheduled for extraction. In
deciduous teeth, class III and IV ART presented 86% failures due to partial or complete loss
already within the first year, and longitudinal data in the permanent dentition are rare.
Survival rates of 71% after three years, and of 68% after six years in the same study cohort
were reported from Brazil.
Basically, ART appears to be an interesting treatment approach as it combines a manual
cavity preparation technique with the use of a glass-ionomer cement as an adhesive and
fluoride releasing restoration material. Biomechanical stress, however, is above-average in
class IV restorations when intending to reconstruct the incisal edge with glass-ionomer
cement resulting in reported high rates of restoration fractures or loss. It was therefore
the aim to evaluate the clinical effectiveness of a modified ART class IV restoration
technique in a clinical study. These data are to be compared with an historical control
(original ART class IV anatomical structure rebuilding restorations). Historical control
data will be retrieved from "Jordan RA, Gaengler P, Markovic L, Zimmer S: Performance of
Atraumatic Restorative Tratment (ART) depending on operator-experience. J Public Health Dent
2010; 70: 176-80."
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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