Endocrown Restorations Longevity Compared With Post Retained Restorations
Primary Purpose
Endodontically Treated Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Endocrown restoration
Post retained composite restoration
Post retained ceramic restoration
Sponsored by
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth
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;
Sites / Locations
- Federal University of Pelotas
- Federal University of PelotasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Semi-direct composite endocrown restorations
Post retained direct composite restoration
Post retained ceramic restoration
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Satisfaction and quality of life improvement
Questionnaire will be applied
Cost-effectiveness
The calculation of cost-effectiveness after treatment delivery will be performed
Full Information
NCT ID
NCT03476304
First Posted
March 14, 2018
Last Updated
November 14, 2018
Sponsor
Federal University of Pelotas
1. Study Identification
Unique Protocol Identification Number
NCT03476304
Brief Title
Endocrown Restorations Longevity Compared With Post Retained Restorations
Official Title
Comparison of Endocrowns Longevity and Post Retained Restorations: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Semi-direct composite endocrown restorations
Arm Type
Experimental
Arm Title
Post retained direct composite restoration
Arm Type
Active Comparator
Arm Title
Post retained ceramic restoration
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Endocrown restoration
Intervention Description
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
Intervention Name(s)
Post retained composite restoration
Intervention Description
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
Intervention Name(s)
Post retained ceramic restoration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Satisfaction and quality of life improvement
Description
Questionnaire will be applied
Time Frame
2 years
Title
Cost-effectiveness
Description
The calculation of cost-effectiveness after treatment delivery will be performed
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Facility Information:
Facility Name
Federal University of Pelotas
City
Pelotas
State/Province
Rs
ZIP/Postal Code
96015-080
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana LS Uehara, Dds
Phone
54 996842421
Email
juliana_lsu@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Tatiana Pereira Cenci, PhD
Phone
53 981114509
Email
tatiana.dds@gmail.com
Facility Name
Federal University of Pelotas
City
Pelotas
State/Province
RS
ZIP/Postal Code
96015560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Cenci, PhD
Phone
555332604230
Email
tatiana.dds@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Endocrown Restorations Longevity Compared With Post Retained Restorations
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