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Clinical Trials/NCT03476304
NCT03476304
Unknown
Not Applicable

Comparison of Endocrowns Longevity and Post Retained Restorations: Randomized Clinical Trial

Federal University of Pelotas1 site in 1 country75 target enrollmentApril 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endodontically Treated Teeth
Sponsor
Federal University of Pelotas
Enrollment
75
Locations
1
Primary Endpoint
Survival
Last Updated
7 years ago

Overview

Brief Summary

Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. It is known that an excellent restorative treatment with poor endodontic treatment and the inverse has a direct impact on the (in) success of the treatment. In this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. Acceptable restorations are those that provide adequate reestablishment of anatomy, function, proximal contacts, and occlusal stability. Traditionally, indirect restorations would be indicated in cases of extensive coronary destruction, because it was believed that they would present greater resistance and longevity when compared to direct restorations. However, contemporary dentistry admits that, thanks to adhesive and conservative principles, this difference between direct and indirect procedures in terms of longevity is not significant. The classic restorative procedure in cases of endodontically treated teeth with great loss of coronary structure involves the use of intraradicular retainers, followed by the creation of core and restoration through total crowns. Removal of healthy tissue for the use of posts can weaken the remaining dental structure and increase the risk of root perforations. In this sense, endocrown restorations show superiority when compared to those made with intraradicular retainers. Although the indications are favorable for the use of endocrown restorations, the clinical evidence available on the subject is still scarce. In this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will will be allocated to one of the three restorative groups available, being endocrown restoration in semi-direct composite resin, direct restoration in composite resin retained on the post and ceramic crown retained in the post. Patients will be monitored annually after completion of restorative treatment outcome. In addition to treatment longevity, other secondary outcomes will be evaluated, such as patient satisfaction, impact on quality of life and cost-effectiveness of the proposed treatments.

Registry
clinicaltrials.gov
Start Date
April 2, 2018
End Date
April 30, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Pelotas
Responsible Party
Principal Investigator
Principal Investigator

Maximiliano Sergio Cenci

PhD

Federal University of Pelotas

Eligibility Criteria

Inclusion Criteria

  • 18 years old or more;
  • healthy volunteers;
  • molars or premolars with endodontic treatment and large coronal destruction;
  • at least 20 teeth;

Exclusion Criteria

  • abutment of removable partial denture ;
  • tooth with mobility higher than 1;
  • more than 1/2 bone loss height;

Outcomes

Primary Outcomes

Survival

Time Frame: 2 years

Tooth will be annually followed until failure, but with a minimal follow-up of two years. They will be evaluated with FDI criteria for evaluation of direct and indirect restorations

Secondary Outcomes

  • Satisfaction and quality of life improvement(2 years)
  • Cost-effectiveness(2 years)

Study Sites (1)

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