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

NCT ID: NCT06311422

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-15

Study Completion Date

2028-09-15

Brief Summary

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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

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Conditions

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Endodontically Treated Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lava Ultimate block

Resin nanoceramic block

Group Type EXPERIMENTAL

resin nanoceramic block

Intervention Type OTHER

Resin-based CAD/CAM materials

Celtra Duo block

zirconia-reinforced lithium silicate block

Group Type ACTIVE_COMPARATOR

zirconia-reinforced lithium silicate

Intervention Type OTHER

zirconia reinforced lithium silicate ceramic

Interventions

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resin nanoceramic block

Resin-based CAD/CAM materials

Intervention Type OTHER

zirconia-reinforced lithium silicate

zirconia reinforced lithium silicate ceramic

Intervention Type OTHER

Other Intervention Names

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Lava Ultimate block Celtra Duo block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Simge Canatan

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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CAD/CAM-endocrown

Identifier Type: -

Identifier Source: org_study_id

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