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Endocrowns vs.Ceramic Onlays Used in Endodontically Treated Teeth- Randomized Clinical Study

NCT03064516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-10-30

No results posted yet for this study

Summary

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%.

Conditions

  • Ceramic Restorations in Endodontically Treated Teeth

Interventions

PROCEDURE

Endocrown

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.

PROCEDURE

Onlay and fiber pin

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.

Sponsors & Collaborators

  • Susana Morimoto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2017-12-20
Completion
2017-12-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03064516 on ClinicalTrials.gov