Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-15

Study Completion Date

2022-09-30

Brief Summary

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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

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Detailed Description

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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

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Dental Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Repair of resin Z350

Repair with Z350 on resin composite proximal

Group Type ACTIVE_COMPARATOR

Repair resin composite proximal

Intervention Type PROCEDURE

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

Repair of Tetric Evo Ceram Bulkfill

Repair with Tetric Evo Ceram on resin composite proximal

Group Type EXPERIMENTAL

Repair resin composite proximal

Intervention Type PROCEDURE

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

Interventions

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Repair resin composite proximal

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes