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

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ART with Equia
ART with Riva Self Cure
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental Atraumatic Restorative Treatment, Primary Teeth, Clinical Efficacy, Cost Analysis, Glass Ionomer Cement

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ART with Equia

ART with Riva Self Cure

Arm Description

Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling.

Occlusal-proximal restoration in primary molars using Riva Self Cure from SDI, encapsulated, pre-dosed and mechanized handling.

Outcomes

Primary Outcome Measures

Longevity of atraumatic restoration
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

Cost-efficacy assessment
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.

Full Information

First Posted
February 22, 2016
Last Updated
November 5, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02730000
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental Atraumatic Restorative Treatment, Primary Teeth, Clinical Efficacy, Cost Analysis, Glass Ionomer Cement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ART with Equia
Arm Type
Active Comparator
Arm Description
Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling.
Arm Title
ART with Riva Self Cure
Arm Type
Experimental
Arm Description
Occlusal-proximal restoration in primary molars using Riva Self Cure from SDI, encapsulated, pre-dosed and mechanized handling.
Intervention Type
Procedure
Intervention Name(s)
ART with Equia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ART with Riva Self Cure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Longevity of atraumatic restoration
Description
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.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Cost-efficacy assessment
Description
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.
Time Frame
an average of 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela P Raggio, Professor
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement

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