Endocrown Restorations Longevity Compared With Post Retained Restorations

NCT03476304 | Unknown

• 1 other identifier: PPGO023
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Survival

  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

  2 years

Secondary Outcomes (2)

• Satisfaction and quality of life improvement

  2 years

• Cost-effectiveness

  2 years

Study Arms (3)

Semi-direct composite endocrown restorations

EXPERIMENTAL

Device: Endocrown restoration

Post retained direct composite restoration

ACTIVE COMPARATOR

Device: Post retained composite restoration

Post retained ceramic restoration

ACTIVE COMPARATOR

Device: Post retained ceramic restoration

Interventions

Endocrown restoration 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

Semi-direct composite endocrown restorations

Post retained composite restoration 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 direct composite restoration

Post retained ceramic restoration 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.

Post retained ceramic restoration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (2)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015-080, Brazil

NOT YET RECRUITING

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015560, Brazil

RECRUITING

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 26, 2018
• Study Start: April 2, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2020
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)