Endocrown Restorations Longevity Compared With Post Retained Restorations

Study 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.

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

Conditions
-----------------
Endodontically Treated Teeth

Intervention / Treatment
-----------------
* Device: Endocrown restoration
* Device: Post retained composite restoration
* Device: Post retained ceramic restoration


Participation Criteria
=================
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semi-direct composite endocrown restorations<br> | Device: Endocrown restoration<br>* 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<br>|
| Active Comparator: Post retained direct composite restoration<br> | Device: Post retained composite restoration<br>* 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.<br>|
| Active Comparator: Post retained ceramic restoration<br> | Device: Post retained ceramic restoration<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction and quality of life improvement | Questionnaire will be applied | 2 years | 
| Cost-effectiveness | The calculation of cost-effectiveness after treatment delivery will be performed | 2 years |