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Report for Clinical Trial NCT03064516

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Endocrowns vs.Ceramic Onlays With Filling and Fiber Pins Used in Endodontically Treated Teeth- Randomized Clinical Study

Objective: To evaluate the immediate and mediate outcomes of endocrowns and onlay ceramic restorations with glass fiber pin in endodontically treated teeth. Material and methods: A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations are evaluated longitudinally by a blind and calibrated examiner using the USPHS. A total of 20 patients will be randomly assigned to each group for a total of 40 patients. The randomization sequence will be generated (www.sealedenvelope.com) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects. In the group of onlays, the teeth receive a fiberglass pin in the main root canal and composite resin filling. In the group of endocrown, only the restoration fill the pulp chamber. The parts are milled in IPS e-max CAD (Ivoclar Vivadent) and cemented with the Multilink cementation system (Ivoclar Vivadent). The immediate clinical (focused in restoration and patient) and mediate (radiographic and clinical) outcomes will be compared between the groups. Survival and success rates will be defined in 24 months. Survival will be established by Kaplan-Meier survival curve and log-rank can be conducted to identify as variables associated with as failures over time. Multivariate analysis with the Cox regression models will be condutcted for the determination of failure predictors. For all analyzes, the significance value will be adjusted to 5%.

NCT03064516 Ceramic Restorations in Endodontically Treated Teeth
MeSH:Tooth, Nonvital

2 Interventions

Name: Endocrown

Description: In experimental group, the researches will be performed in the Endocrown group- only the ceramic restoration will fill the pulp chambre in teeth treated endodontically. Cusps will be preserved.
Type: Procedure
Group Labels: 1

Endocrown

Name: Onlay and fiber pin

Description: In control group, the researches will be performed in the onlay ceramic restorations with glass fiber pin group in endodontically treated teeth- the teeth receive a fiberglass pin in the main root canal and composite resin filling. Cusps will be preserved.
Type: Procedure
Group Labels: 1

Onlay and fiber pin


Primary Outcomes

Description: To evaluate the survival of different restorative treatments.

Measure: Survival of restorations

Time: Up to 24 months

Secondary Outcomes

Description: Evaluate the discomfort of different restorative treatments

Measure: Scale to discomfort

Time: Immediately to restoration procedure

Description: To evaluate the costs of different restorative treatments by total value in dollar of treatment in relation to efficacy. The researchers would like to analyze that a treatment of low cost show the similar efficacy of a high cost treatment.

Measure: Cost-efficacy analysis by total value of treatment in relation to efficacy

Time: Up to 24 months

Description: To evaluate the impact of different restorative treatments in oral health quality of life of patients.

Measure: Questionnaire of Oral health quality of life (OHIP)

Time: Up to 24 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M95L

Session 1- Cavity preparation and casting Endocrown group- Well-defined cervical chamfered finish lines should be created to facilitate the impression and technical procedures, thus a 2-mm round-ended chamfer finish line was created along the margin using tapered inverted cone diamond burs, at high rotation and under cooling, against a 1:5 contra angle multiplier (S-MAX M95L- NSK). --- M95L ---

A 2-mm round-ended chamfer finish line was created along the margin of extracoronal areas using tapered inverted cone diamond burs, at high rotation and under cooling, against a 1:5 contra angle multiplier (1:5 S-Max M95L, NSK). --- M95L ---



HPO Nodes