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Clinical Trials/NCT06311422
NCT06311422
Active, not recruiting
Not Applicable

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

Hacettepe University1 site in 1 country74 target enrollmentMarch 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endodontically Treated Teeth
Sponsor
Hacettepe University
Enrollment
74
Locations
1
Primary Endpoint
Clinical performance of two materials
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2020
End Date
September 15, 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Simge Canatan

principal investigator

Hacettepe University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinical performance of two materials

Time Frame: 36 months

36 months-Modified United States Public Health Service

Study Sites (1)

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