Dental Caries Clinical Trial
Official title:
Effectiveness of Atraumatic Restorative Treatment and Conventional Restorations in Primary and Permanent Dentition: A Practice-based Clinical Trial
Background: Dental caries is still a public health problem among Brazilian children and
doubts still exist regarding the most effective restorative technique. The aim of this
pragmatic randomized clinical trial is to evaluate the effectiveness of single and
multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART)
premises compared with Conventional Treatment (CT) in primary and permanent teeth.
Methods: A total of 1,214 5-to-13 years-old children with at least one single or
multiple-surface dentin caries lesion in primary or permanent molars will be selected in the
public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT
(Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained
dentists in a dental office inside the schools. The restorations will be evaluated after 6,
12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth
survival, the cost-effectiveness analysis between the two groups and the operator preference
of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival
analysis and log-rank test will be applied to the survival of restorations. All the average
event rates in the two groups will be modelled and compared with a Cox proportional hazard
shared frailty model since there is an operator cluster-effect. The significance level for
all analyses will be 5%.
Background: Dental caries is still a public health problem among Brazilian children and
doubts still exist regarding the most effective restorative technique. The aim of this
pragmatic randomized clinical trial is to evaluate the effectiveness of single and
multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART)
premises compared with Conventional Treatment (CT) in primary and permanent teeth.
Methods: A total of 1,214 5-to-13 years-old children with at least one single or
multiple-surface dentin caries lesion in primary or permanent molars will be selected in the
public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT
(Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained
dentists in a dental office inside the schools. The restorations will be evaluated after 6,
12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth
survival, the cost-effectiveness analysis between the two groups and the operator preference
of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival
analysis and log-rank test will be applied to the survival of restorations. All the average
event rates in the two groups will be modelled and compared with a Cox proportional hazard
shared frailty model since there is an operator cluster-effect. The significance level for
all analyses will be 5%.
Discussion: Our hypothesis is that despite similar expected effectiveness between ART using
high viscosity GIC and conventional treatment using composite resin when treating single or
multiple-surface in posterior primary and permanent teeth, ART presents superior
cost-effectiveness. The results of this trial will support decision-making by clinicians and
policy makers
Keywords: atraumatic restorative treatment, composite resin, glass ionomer cement, randomized
clinical trial, cost effectiveness analysis
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