Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial

Dental Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013866
• Other study ID #: DIFO 2017/001
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Universidad Nacional Andres Bello
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Diseases
• Stomatognathic Diseases

Intervention

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

Locations

Country	Name	City	State
Chile	Patricio Vildosola Grez	Santiago	Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Nacional Andres Bello	University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Primary	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).	12 months
Primary	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).	18 months
Primary	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).	24 months