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Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement

U

University of Sao Paulo

Status

Completed

Conditions

Dental Caries

Treatments

Procedure: ART with Riva Self Cure
Procedure: ART with Equia

Study type

Interventional

Funder types

Other

Identifiers

NCT02730000
RIVAART

Details and patient eligibility

About

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.

Full 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).

Enrollment

148 patients

Sex

All

Ages

4 to 8 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children aging between 4 and 8 years
  • presenting good health conditions
  • whose parents or legal guardians accept and sign the consent form
  • with at least one occlusal proximal caries lesion in primary molars
  • only occlusal-proximal surfaces with caries lesions with dentin involvement

Exclusion criteria

  • severe behavioral issues
  • presence of fistula or abscess near the selected tooth
  • presence of pulp exposure in the selected tooth
  • presence of mobility in the selected tooth

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

148 participants in 2 patient groups

ART with Equia
Active Comparator group
Description:
Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling.
Treatment:
Procedure: ART with Equia
ART with Riva Self Cure
Experimental group
Description:
Occlusal-proximal restoration in primary molars using Riva Self Cure from SDI, encapsulated, pre-dosed and mechanized handling.
Treatment:
Procedure: ART with Riva Self Cure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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