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

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.

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Key information

Conditions

Endodontically Treated Teeth Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases Tooth, Nonvital

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry

Ankara, 06060, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resin nanoceramic block

Other

Resin-based CAD/CAM materials

Other names: Lava Ultimate block

zirconia-reinforced lithium silicate

Other

zirconia reinforced lithium silicate ceramic

Other names: Celtra Duo block

Primary outcomes

Clinical performance of two materials

Time frame: 36 months

36 months-Modified United States Public Health Service

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2028
First posted: Mar 15, 2024
Registry last updated: Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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