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

Not Applicable

Active, not recruiting

• Conditions: Endodontically Treated Teeth
• Interventions: Other: zirconia-reinforced lithium silicate; Other: resin nanoceramic block

• Registration Number: NCT06311422
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-15
• Primary Completion: 2023-03-15
• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Study Completion: 2028-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celtra Duo block	zirconia-reinforced lithium silicate	zirconia-reinforced lithium silicate block
Lava Ultimate block	resin nanoceramic block	Resin nanoceramic block

Primary Outcome Measures

Name	Time	Method
Clinical performance of two materials	36 months	36 months-Modified United States Public Health Service

Trial Locations

Locations (1)

Hacettepe University Faculty of Dentistry; 🇹🇷 Ankara, Turkey