Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Given the clinical damage caused by errors commonly made during the dosage and handling of
      glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated
      ionomer has been recommended for final restorations. However, the initial cost of the
      encapsulated MIC is higher when compared to the material handled manually. The objective of
      this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV
      Riva Self Cure and Equia used as a restorative material in atraumatic restorations
      (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and
      occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC,
      (3) assess whether the child's caries experience influences the longevity of atraumatic
      restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP
      municipality. Randomization will be performed in a stratified manner by the conditions: type
      of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV -
      Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and
      18 months by two trained examiners blind to the groups (intra- and inter-rater agreement
      above 0.7). To verify the survival of the restorations will be used Kaplan-Meier survival
      analysis and log-rank test. To evaluate the association between longevity and variable Cox
      regression test will be applied. For the cost analysis will be used analysis of variance.
    

Detailed description: 
      Given the clinical damage caused by errors commonly made during the dosage and handling of
      glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated
      ionomer has been recommended for final restorations. However, the initial cost of the
      encapsulated MIC is higher when compared to the material handled manually. The objective of
      this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV
      Riva Self Cure and Equia used as a restorative material in atraumatic restorations
      (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and
      occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC,
      (3) assess whether the child's caries experience influences the longevity of atraumatic
      restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP
      municipality. Randomization will be performed in a stratified manner by the conditions: type
      of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV -
      Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and
      18 months by two trained examiners blind to the groups (intra- and inter-rater agreement
      above 0.7).
    

Intervention name(s): ART with Equia; ART with Riva Self Cure
Intervention type(s): Procedure; Procedure
Intervention description(s): Occlusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.; Occlusal-proximal ART restorations in primary molars using Riva Self Cure will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental Atraumatic Restorative Treatment; Primary Teeth; Clinical Efficacy; Cost Analysis; Glass Ionomer Cement