Investigation of the Clinical Outcomes of Endocrowns Manufactured From Three Different Materials

The goal of this clinical trial is to examine the durability of endocrowns, created using various materials and manufacturing techniques with a fully digital workflow, and their ability to maintain functionality and aesthetics in the oral cavity.

The main questions it aims to answer were does effect of different materials on clinical success?

Study Overview

• Status: Completed
• Conditions: No Systemic Infection; Gross Material Loss in Endodontically Treated Upper and Lower Molars; Gingival Steps Should be at Gum Level
• Intervention / Treatment: Other: endocrowns

Detailed Description

Based on the power analysis, it was determined that restorations would be applied to 11 teeth in each of the three material groups (lithium-disilicate reinforced glass-ceramic, polymer infiltrated ceramic, and 3D-printed permanent hybrid resin) as well as the control group (n=11). A total of 33 teeth received endocrown restorations. Additionally, 11 patients were directly restored with composite resin in molar teeth with MOD cavities.

The digital impressions of the patients receiving endocrown restorations were recorded using an intraoral optical scanner and sent to a specialized dental laboratory. For two of the groups (lithium disilicate-reinforced glass-ceramic, polymer infiltrated ceramic), restorations were fabricated using block milling, while for the third group (permanent hybrid resin), restorations were produced through 3D printing. The restorations were cemented adhesively. The restorations were evaluated using the Modified FDI and Modified USPHS criteria at baseline (0) and at the 6-month follow-up, and the data were subjected to statistical analysis.

At the 6-month evaluation, a statistically significant difference in color match was found between the groups based on the Modified FDI criteria, whereas no statistically significant differences were observed for any of the Modified USPHS criteria. All endocrowns produced with the three different materials survived and showed clinical success at the 6-month follow-up. Nevertheless, additional clinical studies with extended follow-up durations are required.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Must be a lower or upper molar tooth
• Must be periodontal healthy
• There must be at least two axial walls in the relevant tooth
• Gingival steps should be at gum level
• There must be neighboring teeth mesial and distal to the relevant tooth.
• The place where it occludes must be the opposing tooth and the tooth must be a natural or filled tooth without a prosthesis.
• No systemic acut or chronic conditions (Thyroid disease, Alzheimer's Disease, Insulin dependent diabetes, etc.)

Exclusion Criteria:

• Inadequate oral hygiene, bleeding on probing, pocket deeper than 3 mm mobility presence
• Sensitivity to percussion after root canal treatment
• Insufficient enamel tissue remaining in the relevant tooth
• Presence of radiographically abnormal periodontal space
• Teeth with inadequate bone support
• Teeth with root resorption and fracture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endocrown Materials; IPS Empress CAD Vita Enamic VarseoSmile Crown Plus	Other: endocrowns; IPS Empress CAD Vita Enamic VarseoSmile Crown Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes	Restorations were checked clinically at the time of delivery and 6 months later. A 0.15 mm probe (DEPPELER 150EX, Rolle, Switzerland) was used for the controls. Modified USPHS and modified FDI criteria (revised 2023) were used in the evaluations. The modified USPHS criteria were recorded as Alpha (A), Bravo (B), Charlie (C), Delta (D), and the modified FDI criteria were recorded as very good, good, adequate, unsatisfactory, and failed. 'Surface Luster, Surface and Marginal Staining, Colour match and Translucency, Esthetic Anatomical Form, Fracture Material and Retention, Marginal adaptation as Modified FDI Criteria and Marginal Discoloration, Marginal Integrity, Surface Texture, Wear, Postoperative Sensitivity and Recurrent Caries as Modified USPS Criteria were evaluated. In the study, the headings of the result measurement tables will be created as follows: Comparison of Baseline Modified USPHS Values According to Groups Comparison of Baseline Modified FDI Values According to G	6 month

Collaborators and Investigators

• Sponsor: Gulcan COSKUN AKAR

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: CAD-CAM; endodontic treatment; endocrown
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: E-61749811-000-1963653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No