An interventional study of Repair resin composite proximal in Dental Diseases, sponsored by Universidad Nacional Andres Bello. Completed at 1 site in Chile. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Universidad Nacional Andres Bello · Not applicable, Interventional, and Treatment
Bulk Fill" (RBF) composite resins (RC) has been on the market, with the main advantage of being applied in a single layer, faster and easier than a conventional RC. Repair of RC restorations is a validated treatment option in dentistry, which has been shown to increase the longevity of restorations by minimizing tooth damage such as complete replacement. Currently there are no clinical studies that support the actual performance of RBF repair
Main objective: Compare the clinical performance with FDI of repairs proximal RC restorations between a conventional resin and a RBF in a period of 24 months. Hypothesis: There is not different clinical performance of proximal RC repairs done with RBF when compared to conventional RC repairs. Material and method: 80 volunteer patients will be randomly recruited to attend the clinic of the Faculty of Dentistry of the University of Chile who have two proximal RC restorations with indication of repair according to the FDI system (n per group = 80). Each patient must accept and sign an informed consent. The repairs will be randomly divided into two groups on the same patient. Control Group: Conventional RC repair (Z350 XT). Experimental Group: RBF (Tetric Evoceram Bulk Fill) Repair. For the restorative technique, a three-step adhesive with acid-etched enamel-dentin will be used. It will be evaluated at 2 weeks (Baseline), at 6, 12, 18, 24 months by two blind and calibrated evaluators (Cohen Kappa> 0.8). The data will be analyzed with the SSPS 21.0 software and the Friedman, Wilcoxon and Mann Whitney tests will be applied with a significance level of 95%.
110 studies on the registry are indexed under Stomatognathic Diseases; 26 are open to participants now.
This study's enrollment of 40 is below the median of 59 across 86 interventional studies indexed under Stomatognathic Diseases.
Browse Stomatognathic Diseases studies →Universidad Nacional Andres Bello is the lead sponsor of 23 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Repair with Z350 on resin composite proximal
Procedure: Repair resin composite proximal
Repair with Tetric Evo Ceram on resin composite proximal
Procedure: Repair resin composite proximal
Repair proximal composite resin restoration, removing the defective material and then restoring it with another composite resin
Clinical Performance
Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).
Time frame: Baseline
Clinical Performance
Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).
Time frame: 12 months
Clinical Performance
Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).
Time frame: 18 months
Clinical Performance
Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).
Time frame: 24 months
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Universidad Nacional Andres Bello