A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials

March 17, 2024 updated by: Simge Canatan, Hacettepe University

A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials Using The Computer-Aided Design/ Computer-Aided Manufacture (Cad/Cam) System

The clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. All endocrown restorations will be produced using the same CAD/CAM system. 52 restorations will be fabricated using Lava Ultimate (LU, 3M Espe, Seefeld, Germany) blocks and 38 restorations will be fabricated using Celtra Duo (CD, Dentsply Sirona, York, PA, USA) blocks. All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12,36, 48, 60 months. Descriptive statistics will be performed using Chi-square and Fisher exact test.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06060
        • Hacettepe University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Good general health
  • Patients older than 18
  • Teeth must receive endodontic therapy before restoration
  • The periodontal condition had to be stabilized before restoration
  • No subject complained of discomfort in teeth
  • Radiograph revealing alveolar bone resorption of less than a third and no shadow around the periapical tissues
  • Participants who provided writen informed consent were recruited in collaboration

Exclusion Criteria:

  • Any teeth with microcracks or fracture lines
  • Affected teeth without completed root canal treatment
  • The defect was less than ¼ of crown or more than ¾ of the crown and the margin of the residual crown was more than 1 mm below the gingival level
  • Poor oral hygiene and periodontal status which persisted or worsened after periodontal therapy and education
  • Bruxism or clenching patients
  • Poor general health or pregnancy
  • Patients who have read the informed consent form and refused to be included in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lava Ultimate block
Resin nanoceramic block
Other: resin nanoceramic block
Resin-based CAD/CAM materials
Other Names:
  • Lava Ultimate block
Active Comparator: Celtra Duo block
zirconia-reinforced lithium silicate block
Other: zirconia-reinforced lithium silicate
zirconia reinforced lithium silicate ceramic
Other Names:
  • Celtra Duo block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance of two materials
Time Frame: 36 months
36 months-Modified United States Public Health Service
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2020

Primary Completion (Actual)

March 15, 2023

Study Completion (Estimated)

September 15, 2028

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAD/CAM-endocrown

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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