Clinical trial NCT02730000: Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement
Official title: Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental Atraumatic Restorative Treatment
Primary Teeth
Clinical Efficacy
Cost Analysis
Glass Ionomer Cement
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 148
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Longevity of atraumatic restoration
timeFrame: up to 24 months
Secondary outcomes:
measure: Cost-efficacy assessment
timeFrame: an average of 24 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Daniela P Raggio, Professor
role: PRINCIPAL_INVESTIGATOR
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