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OpenTrials
Completed

NCT Number: NCT06850649

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?

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Endocrowns

Other

IPS Empress CAD Vita Enamic VarseoSmile Crown Plus

Primary outcomes

  1. Clinical Outcomes

    Time frame: 6 month

    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

Sponsors and collaborators

Lead sponsor

Gulcan COSKUN AKAR

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Mar 3, 2025

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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