Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial

Not Applicable

Completed

• Conditions: Dental Diseases
• Interventions: Procedure: Repair resin composite proximal

• Registration Number: NCT05013866
• Lead Sponsor: Universidad Nacional Andres Bello

Brief 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%.

Study Timeline

• Study Start: 2016-08-15
• Primary Completion: 2017-09-01
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-19
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• > 18 years,
• healthy
• high cariogenic risk,
• Vital molars and premolars,
• Natural antagonist and proximal
• Indication of repair in the proximal with depth> 2mm.

Exclusion Criteria

• Patients has xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients -inability to perform hygiene
• pregnant women
• severe bruxism
• Prosthesis
• Not absolute isolation
• Tooth fracture and / or restoration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repair of Tetric Evo Ceram Bulkfill	Repair resin composite proximal	Repair with Tetric Evo Ceram on resin composite proximal
Repair of resin Z350	Repair resin composite proximal	Repair with Z350 on resin composite proximal

Primary Outcome Measures

Name	Time	Method
Clinical Performance	24 months	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).

Trial Locations

Locations (1)

Patricio Vildosola Grez; 🇨🇱 Santiago, Metropolitana, Chile