Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03476304
Other study ID # PPGO023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2, 2018
Est. completion date April 30, 2020

Study information

Verified date November 2018
Source Federal University of Pelotas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date April 30, 2020
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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
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.
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.

Locations

Country Name City State
Brazil Federal University of Pelotas Pelotas Rs
Brazil Federal University of Pelotas Pelotas RS

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Satisfaction and quality of life improvement Questionnaire will be applied 2 years
Secondary Cost-effectiveness The calculation of cost-effectiveness after treatment delivery will be performed 2 years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06447519 - Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not? N/A
Not yet recruiting NCT05476419 - Apical Gap Length and Adaptation of Zirconia Post Using Intraoral and Extraoral Scan of Silicon Impression Technique N/A
Completed NCT03478241 - Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems N/A
Recruiting NCT04528979 - Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer N/A
Recruiting NCT04527705 - Outcome of Endodontic Retreatment in One or Two Visits N/A
Completed NCT05381298 - Deep Margin Elevation Vs Crown Lengthening N/A
Active, not recruiting NCT03161639 - Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth N/A
Completed NCT06226740 - Effectiveness of Different Obturation Techniques N/A
Completed NCT04310254 - Effect of Different Final Irrigation Protocols on Postoperative Endodontic Pain in Devital Teeth N/A
Completed NCT03841370 - Tooth Crown Discoloration Caused by Endodontic Treatment
Recruiting NCT03704857 - Different Endodontic Treatment Techniques in Postoperative Symptoms, Apical Repair, Longevity of Rehabilitations, and Oral Health-related Quality of Life N/A
Completed NCT04518371 - Clinical Performance of Milled Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year N/A
Completed NCT04638972 - Accuracy of Apex Locators in Primary Teeth
Completed NCT04561167 - Clinical Performance of the Indirect Resin Composite Restorations in Endodontically Treated Teeth N/A
Not yet recruiting NCT04580862 - Postoperative Pain Endodontic Retreatment N/A
Completed NCT04511117 - Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up N/A
Recruiting NCT05084742 - Long-term Performance and Safety of Biodentineā„¢ in Patients Treated for Endodontic Indications
Not yet recruiting NCT04023357 - Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns. N/A
Not yet recruiting NCT03713918 - Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate N/A
Not yet recruiting NCT06450938 - No Code Artificial Intelligence to Detect Radiographic Features Associated With Unsatisfactory Endodontic Treatment N/A