Clinical Performance of Full Coverage Hybrid Ceramic Crowns in the Aesthetic Zone: A Randomized Clinical Trial

NCT07264491 | Recruiting DMC

• 1 other identifier: CEBD-CU-2025-05-26
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will receive high-quality dental restorations, installed and monitored by qualified dental professionals regular periodic follow up recalls will be assigned early detect any consequences free of charge repairs or remakes for any failed dental restorations this research will help in the improvement of the tested materials

Conditions

Poor Aesthetic of Existing Restoration of Tooth; Dental Restoration Failure of Marginal Integrity

Keywords

clinical outcome- hybrid ceramics- resin cements; full coverage- marginal discrepancy

Outcome Measures

Primary Outcomes (1)

• marginal adaptation

  measurement of vertical and horizontal discrepancies at the margins of dental restorations

  from enrollment to the end of treatment at 18 months

Secondary Outcomes (1)

• Color match

  from enrollment to the end of treatment at 18 months

Study Arms (2)

Vita Enamic Hybrid Ceramic full coverage Crowns

ACTIVE COMPARATOR

Polymer-infiltrated-ceramic-network material (Vita Enamic)

Other: Shofu HC Hard full coverage corwns

Shofu Hard HC full coverage crowns

EXPERIMENTAL

highly esthetic ceramic-based restorative (hybrid ceramics) for milling into dental restorations using a dental CAD/CAM system.

Other: Vita Enamic full coverage crowns

Interventions

Vita Enamic full coverage crowns OTHER

hybrid cermaics

Shofu Hard HC full coverage crowns

Shofu HC Hard full coverage corwns OTHER

HC HARD hybrid ceramic crowns

Vita Enamic Hybrid Ceramic full coverage Crowns

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients requiring full coverage crowns in aesthetic zone
• Age ≥ 21 years
• Vital or endodontically treated teeth
• Willing and able to provide written informed consent
• Ability to attend all follow-up appointments
• Adequate oral hygiene as determined by the investigator

You may not qualify if:

• Patients with active periodontal disease (probing depth \> 4mm, bleeding on probing)
• Patients with parafunctional habits (e.g., bruxism confirmed by clinical examination)
• Poor oral hygiene (plaque index \> 30%)
• Systemic diseases affecting treatment outcomes (e.g., uncontrolled diabetes, immunosuppression)
• Known allergies to study materials (ceramic materials, or resin cement components)
• Inability to comply with study requirements
• Current participation in other dental clinical trials

Sponsors & Collaborators

• Karim Ahmed Awadallah Osman: lead

Study Sites (1)

Faculty Of Dentistry, Cairo University

Cairo, Manial, Egypt

RECRUITING

Related Publications (1)

• Giordano, R. (2016). Materials for chairside CAD/CAM-produced restorations. Journal of the American Dental Association, 147(12), 972-980. https://doi.org/10.1016/j.adaj.2016.07.002 (Overview of hybrid ceramics used in CAD/CAM and their esthetic/mechanical advantages.)

  BACKGROUND

Study Officials

• Reham Elbasty, MSC, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Karim A Awadallah, MSC, PhD

CONTACT

+201006247666; karimawadallah@dentistry.cu.edu.eg

Omnia Nabil, MSC, PhD

CONTACT

+201222201179; omnianabil84@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, Fixed Prosthodontics Department, Faculty of Dentistry, Cairo University

Model Details: Model Description

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: December 4, 2025
• Study Start: September 20, 2025
• Primary Completion: November 10, 2025
• Study Completion (Estimated): May 10, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)