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

NCT06311422 | Active Not Recruiting DMC

• 1 other identifier: CAD/CAM-endocrown
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontically Treated Teeth

Keywords

CAD/CAM; Endocrown; resin nanoceramic; zirconia-reinforced lithium silicate

Outcome Measures

Primary Outcomes (1)

• Clinical performance of two materials

  36 months-Modified United States Public Health Service

  36 months

Study Arms (2)

Lava Ultimate block

EXPERIMENTAL

Resin nanoceramic block

Other: resin nanoceramic block

Celtra Duo block

ACTIVE COMPARATOR

zirconia-reinforced lithium silicate block

Other: zirconia-reinforced lithium silicate

Interventions

resin nanoceramic block OTHER

Resin-based CAD/CAM materials

Also known as: Lava Ultimate block

Lava Ultimate block

zirconia-reinforced lithium silicate OTHER

zirconia reinforced lithium silicate ceramic

Also known as: Celtra Duo block

Celtra Duo block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Dentistry

Ankara, 06060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: March 15, 2020
• Primary Completion: March 15, 2023
• Study Completion (Estimated): September 15, 2028
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

TU (1)