NCT05013866

Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial

Repair of Proximal Restoration With Resin Composite Bulk-Fill. Double Blind Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Universidad Nacional Andres Bello · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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%.

Conditions

• Dental Diseases

Interventions

Type	Name	Description
PROCEDURE	Repair resin composite proximal	Repair proximal composite resin restoration, removing the defective material and then restoring it with another composite resin

Timeline

• Start date: 2016-08-15
• Primary completion: 2017-09-01
• Completion: 2022-09-30
• First posted: 2021-08-19
• Last updated: 2022-11-04

Locations

1 site across 1 country: Chile