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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 two 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 34 patients will be randomly assigned to each group for a total of 68 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 6, 12 and 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%.

Detailed Summary:
Sponsor: Susana Morimoto

Current Primary Outcome: Survival of restorations [ Time Frame: Up to 24 months ]

To evaluate the survival of different restorative treatments.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Scale to discomfort [ Time Frame: Immediately to restoration procedure ]
    Evaluate the discomfort of different restorative treatments
  • Cost-efficacy analysis by total value of treatment in relation to efficacy [ Time Frame: Up to 24 months ]
    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.
  • Questionnaire of Oral health quality of life (OHIP) [ Time Frame: Up to 24 months ]
    To evaluate the impact of different restorative treatments in oral health quality of life of patients.


Original Secondary Outcome:

  • Scale to discomfort [ Time Frame: Immediately to restoration procedure ]
    Evaluate the discomfort of different restorative treatments
  • Cost-efficacy analysis by total value of treatment in relation to efficacy [ Time Frame: Up to 24 months ]
    To evaluate the cost-efficacy 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.
  • Questionnaire of Oral health quality of life (OHIP) [ Time Frame: Up to 24 months ]
    To evaluate the impact of different restorative treatments in oral health quality of life of patients.


Information By: Universidade Ibirapuera

Dates:
Date Received: February 22, 2017
Date Started: March 10, 2017
Date Completion: December 20, 2019
Last Updated: May 3, 2017
Last Verified: May 2017