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Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial

Primary Purpose

Dental Diseases

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Repair resin composite proximal
Sponsored by
Universidad Nacional Andres Bello
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Diseases focused on measuring Composite Dental Resin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Patricio Vildosola Grez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Repair of resin Z350

Repair of Tetric Evo Ceram Bulkfill

Arm Description

Repair with Z350 on resin composite proximal

Repair with Tetric Evo Ceram on resin composite proximal

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
August 4, 2021
Last Updated
November 2, 2022
Sponsor
Universidad Nacional Andres Bello
Collaborators
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT05013866
Brief Title
Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial
Official Title
Repair of Proximal Restoration With Resin Composite Bulk-Fill. Double Blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional Andres Bello
Collaborators
University of Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases
Keywords
Composite Dental Resin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repair of resin Z350
Arm Type
Active Comparator
Arm Description
Repair with Z350 on resin composite proximal
Arm Title
Repair of Tetric Evo Ceram Bulkfill
Arm Type
Experimental
Arm Description
Repair with Tetric Evo Ceram on resin composite proximal
Intervention Type
Procedure
Intervention Name(s)
Repair resin composite proximal
Intervention Description
Repair proximal composite resin restoration, removing the defective material and then restoring it with another composite resin
Primary Outcome Measure Information:
Title
Clinical Performance
Description
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
Title
Clinical Performance
Description
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
Title
Clinical Performance
Description
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
Title
Clinical Performance
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricio Vildosola
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patricio Vildosola Grez
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7510583
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial

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