Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement
- Conditions
- Dental Caries
- Interventions
- Procedure: ART with EquiaProcedure: ART with Riva Self Cure
- Registration Number
- NCT02730000
- Lead Sponsor
- University of Sao Paulo
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ART with Equia ART with Equia Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling. ART with Riva Self Cure ART with Riva Self Cure Occlusal-proximal restoration in primary molars using Riva Self Cure from SDI, encapsulated, pre-dosed and mechanized handling.
- Primary Outcome Measures
Name Time Method Longevity of atraumatic restoration up to 24 months The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failure" will be analyzed. "Minor failures" are those in which there is a defect in the restoration/crown, but it does not interfere with the tooth health.
- Secondary Outcome Measures
Name Time Method Cost-efficacy assessment an average of 24 months Treatment costs will be calculated considering professional costs and procedure costs. In order to calculate the professional cost the time spent in each session will be converted in hours and multiplied by the medium income of the dentist per hour as related by the Brazilian Ministry of Labour and Employment ($36,23). On the other hand, to estimate the procedure cost, it will be considered both variable cost, which includes electricity and equipment depreciation, and materials cost. To calculate the equipment depreciation (peripherals, dental chair and instrumental), the investigators will consider their price, the lifespan of five years and a monthly use of 160 hours, using an estimate value per hour of $1,81. All materials used in each procedure will have their specifications and quantity registered. Prices will be inferences from the market value converted in US Dollars and obtained by the medium of the values from different places that commercialized the referred products.
Trial Locations
- Locations (1)
University of Sao Paulo
🇧🇷Sao Paulo, Brazil