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

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06311422
• Other study ID #: CAD/CAM-endocrown
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: September 15, 2028

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: September 15, 2028
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

Other:
• resin nanoceramic block
Resin-based CAD/CAM materials
• zirconia-reinforced lithium silicate
zirconia reinforced lithium silicate ceramic

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Dentistry	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance of two materials	36 months-Modified United States Public Health Service	36 months