NCT06850649

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

February 7, 2025

Last Update Submit

February 27, 2025

Conditions

Keywords

endodontic treatmentCAD-CAMendocrown

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Endocrown Materials

EXPERIMENTAL

IPS Empress CAD Vita Enamic VarseoSmile Crown Plus

Other: endocrowns

Interventions

IPS Empress CAD Vita Enamic VarseoSmile Crown Plus

Endocrown Materials

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ege University Scientific Research Project

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 27, 2025

Study Start

May 15, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations