Effect of Pre-etching of Dentin on Survival of Restorations With High Viscosity Glass Ionomer Cement in the Atraumatic Restorative Treatment - Randomized Clinical Trial Restorations With High Viscosity Glass Ionomer Cement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Universidade Ibirapuera
- Locations
- 2
- Primary Endpoint
- Survival of restorations
Study Overview
Brief Summary
The objective of this randomized clinical trial is to evaluate the survival of restoration with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid compared with no pre-etching in order to treat occlusoproximais caries lesion in primary molars, as well as the impact of those treatments in the caries lesion progression, the cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to 8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192 teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious lesions progression will be evaluated after 24 months of follow-up. The time of the treatments and the cost of the materials will be considered to estimate the cost-efficacy of each treatment. The discomfort reported by the participant will be measured after each procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and the Long-Rank test will be used in order to compare the two groups. Cox regression will be performed in order to evaluate thee influence of explanatory variables on the outcome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Double-blind (Patient and Examiner) will not be able to blinding the operator due to the obvious difference between the techniques
Eligibility Criteria
- Ages
- 4 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with carious lesion of occlusoproximais in primary molars
Exclusion Criteria
- •Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
- •Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.
Outcomes
Primary Outcomes
Survival of restorations
Time Frame: 24 months
Comparing the survival of HVGIC restorations without pre-etching with HVGIC restorations with pre-etching by clinical assessment using a criteria proposed by Roleveld et al., 2006.
Secondary Outcomes
- Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration(Immediately after the restoration and 24 months)
- Cost-efficacy(24 months.)
- Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale(Immediately after the treatment)
Investigators
Tamara Kerber Tedesco
Principal investigator
Universidade Ibirapuera