Clinical Criteria for the Evaluation of Caries Lesions Around Restorations in Primary Teeth (CARDEC-03)
Condition: Dental Caries; Secondary Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      There is still great divergence in the aspects related to caries lesions around restorations.
      The methods and the systems used for the detection of secondary caries lesions have presented
      low validity. Also, the consequent treatment decisions of this kind of lesions have presented
      a lot of variation. However, the correct diagnosis of secondary caries may guarantee greater
      longevity to the restorative treatment, as well as oral health to the patients, reducing the
      cost and clinical time of the dentists. Therefore, the investigators aimed to perform this
      study to evaluate and compare two visual criteria for the evaluation of restorations in
      primary teeth in medium and long term outcomes for the patients, through a randomized
      clinical study. These criteria are the system proposed by the World Dental Federation (FDI)
      and the International Caries Classification and Management System - ICCMS.
    

Detailed description: 
      Among the available diagnosis criteria to detect caries lesions around restorations, there
      are the World Dental Federation (FDI) criteria and the International Caries Classification
      and Management System - ICCMS. However, few studies have evaluated the accuracy of both
      methods. The impact of the use of these methods in the treatment decisions regarding the
      restorations was also not evaluated. In relation to the detection of caries lesions around
      restorations in primary teeth, no randomized clinical study was performed, so the aim of this
      study is to establish the best diagnosis and treatment decision to caries around restorations
      in children. For this, three different studies will be carried out according the following
      specific aims: (1) to evaluate the accuracy of the FDI criteria and the system proposed by
      the ICCMS for the evaluation of caries lesions around restorations in primary teeth through a
      cross-sectional study design; (2) to evaluate the impact and cost of using these two criteria
      in treatment decisions related to the evaluation of restorations in primary teeth through a
      cross-sectional study design; (3) to evaluate the influence of the use of these two criteria
      for the evaluation of restorations in primary teeth in medium and long term outcomes for the
      patients, through a randomized clinical trial. To reach these objectives 626 restorations
      will be evaluated in children from 3 to 10 years who have looked for dental treatment in our
      dental school. They will be randomly allocated in two groups according to the diagnostic
      strategy used for caries detection around restorations: diagnosis and treatment decision
      based on the criteria of the International Dental Federation (FDI) (control group) or
      diagnosis and treatment decision based on the CARS detection criteria and treatment decision
      proposed by the ICCMS (experimental group). The consequent treatment decision of the
      restorations will be divided into no restorative intervention; repair or replacement of the
      restorations. Children will be treated by dentists, blinded to the criteria used to reach the
      treatment decision and then, will be monitored for two years. Reassessments will be performed
      by a blind examiner in relation to the child's allocation group, and the occurrence of
      outcomes will be assessed according to predefined criteria described for evaluation of
      restorations performed in the context of atraumatic restorative treatment. The primary
      outcome will be the need for restorative intervention during the follow-up of the
      restorations evaluated by the different criteria. This outcome is composed of several
      components. The reference standard will be the presence of caries lesion adjacent to the
      restoration after removal of the restoration, and their occurrence will be compared among the
      methods by survival analysis.
    

Intervention name(s): Dental treatment
Intervention type(s): Procedure
Intervention description(s): Treatment of all dental restorations of the children according to the diagnosis criteria
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Diagnosis; Visual inspection; Quality of Life; Restorations