Endocrown Restorations Longevity Compared With Post Retained Restorations

NCT ID: NCT03476304

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-02
• Study Completion Date: 2020-04-30

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.

Conditions

Endodontically Treated Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Semi-direct composite endocrown restorations

Group Type: EXPERIMENTAL

Endocrown restoration

Intervention Type: DEVICE

The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with resin composite in a cast and cemented with self adhesive cement

Post retained direct composite restoration

Group Type: ACTIVE_COMPARATOR

Post retained composite restoration

Intervention Type: DEVICE

The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and a semi direct composite restoration will be cemented with self adhesive cement.

Post retained ceramic restoration

Group Type: ACTIVE_COMPARATOR

Post retained ceramic restoration

Intervention Type: DEVICE

The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and a ceramic restoration will be cemented with self adhesive cement.

Interventions

Endocrown restoration

The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with resin composite in a cast and cemented with self adhesive cement

Intervention Type: DEVICE

Post retained composite restoration

The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and a semi direct composite restoration will be cemented with self adhesive cement.

Intervention Type: DEVICE

Post retained ceramic restoration

The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and a ceramic restoration will be cemented with self adhesive cement.

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Pelotas

OTHER

Sponsor Role: lead

Responsible Party

Maximiliano Sergio Cenci

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Pelotas

Pelotas, Rio Grande do Sul, Brazil

Site Status: NOT_YET_RECRUITING

Federal University of Pelotas

Pelotas, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Juliana LS Uehara, Dds

Role: primary

juliana_lsu@yahoo.com.br

54 996842421

Tatiana Pereira Cenci, PhD

Role: backup

tatiana.dds@gmail.com

53 981114509

Tatiana Cenci, PhD

Role: primary

tatiana.dds@gmail.com

555332604230

Other Identifiers

PPGO023

Identifier Type: -

Identifier Source: org_study_id