Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Sao Paulo
- Enrollment
- 428
- Locations
- 1
- Primary Endpoint
- The restoration survival
Study Overview
Brief Summary
The aim of this randomized clinical trial study is to compare the longevity of Atraumatic Restorative Treatment (ART) using high viscosity GIC and Conventional Treatment using composite resin under rubber dam isolation and local anesthesia (CT) in primary molars. As secondary outcomes, cost-efficacy, self-reported discomfort and cooperation will also be tested. Children aging between 3 to 6 years old presenting at least one occlusal and/or occlusoproximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or CT (control group). The dental treatment will be performed at a dental care trailer located in a Public School in Barueri (São Paulo, Brazil). The unit of analysis for randomization will be the child. A number of 204 teeth presenting occlusal cavities and 240 teeth presenting occlusoproximal cavities were set after sample size calculation. The primary outcome will be the restorations' longevity, which will be assessed after 6, 12, 18 and 24 months by two evaluators through clinical examination according to Frencken et al. (1998) criteria for occlusal restorations and Roeleveld et al. (2006) criteria for occlusoproximal restorations. The time spent during the dental treatment and all materials used will be considered for estimating the cost-efficacy of each treatment. The individual's discomfort will be also measured after each dental procedure using the Facial Scale of Wong-Baker. Cooperation will be assessed by the operator using a 5-point scale.
Detailed Description
Research setting
The study will be performed in a dental care trailer which simulated a regular dental office and it is located inside a public school of the city Barueri (São Paulo, Brazil).
Sample size calculation
For sample size calculation, data regarding longevity of CT in occlusal and occlusoproximal restorations after 2 years were extracted from the literature as 86% for occlusal and 60% for occlusoproximal restorations. A difference of 15% and 20% between the longevity of CT and ART was set as non-inferiority limit. Considering the level of significance as 5%, power as 80% and adding 40% due to the study design (cluster per child), a number of 204 occlusal restorations and 240 occlusoproximal restorations will be needed.
Randomization
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children aging between 3 and 6 years
- •presenting good health conditions
- •whose parents or legal guardians accept and sign the consent form
- •with at least one occlusal or occlusal proximal caries lesion in primary molars
- •only occlusal and/or 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
Arms & Interventions
Conventional Treatment
Occlusal and occlusoproximal composite resin restorations in primary molars (rubber dam isolation + Adhesive system + composite resin Filtek z350)
Intervention: Conventional Treatment (Procedure)
ART using Fuji IX
Occlusal and occlusoproximal ART restorations in primary molars with GIC Fuji IX
Intervention: ART using Fuji IX (Procedure)
Outcomes
Primary Outcomes
The restoration survival
Time Frame: Every 6 months up to 24 months.
The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failures" 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 Outcomes
- Child self-reported discomfort(Immediately after treatment)
- Cost-efficacy assessment(Through study completion, an average of 24 months)
- Cooperation(Immediately after treatment)
Investigators
Daniela Prócida Raggio
Associate Professor of Pediatric Dentistry Department
University of Sao Paulo