Clinical trial NCT05013866: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Diseases
Keywords: Composite Dental Resin
Lead sponsor: Universidad Nacional Andres Bello
Sponsor class: OTHER
Collaborators: name: University of Chile
First posted: 2021-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: Clinical Performance
timeFrame: Baseline
measure: Clinical Performance
timeFrame: 12 months
measure: Clinical Performance
timeFrame: 18 months
measure: Clinical Performance
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Patricio Vildosola Grez
state: Metropolitana
Study officials:
affiliation: University of Chile
name: Patricio Vildosola
role: PRINCIPAL_INVESTIGATOR
References: