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

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

Study Overview

• Status: Recruiting
• Conditions: Dental Restoration Failure of Marginal Integrity; Poor Aesthetic of Existing Restoration of Tooth
• Intervention / Treatment: Other: Shofu HC Hard full coverage corwns; Other: Vita Enamic full coverage crowns

Detailed Description

Direct benefit of the research to the human volunteer:

• Participants will receive high-quality dental restorations (hybrid ceramic full coverage restorations) fabricated using standardized protocols and materials.
• All participants will have their restorations placed by qualified dental professionals in a controlled clinical environment, ensuring proper technique and follow-up care.
• Participants will benefit from regular follow-up examinations at 6, 12, and 18 months, which allows for early detection and management of any potential issues with their restorations.
• Any issues or failures identified during the follow-up period will be documented and repaired at no additional cost to the participant.
• Participants will contribute to advancing dental knowledge regarding optimal hybrid ceramic materials, which may lead to improved treatment protocols and long-term outcomes for future dental patients.
• The research provides an opportunity for comprehensive oral health monitoring beyond just the restoration itself, potentially identifying other dental issues that might require attention.

The scientific interest and the desired public benefit of the research:

Scientific Interest

1. This research will help understanding the material-specific outcomes in terms of marginal adaptation, color match, retention, surface texture, and restoration failure
2. The study will contribute to the understanding of the relationship between laboratory findings and clinical outcomes for dental materials, particularly regarding hybrid ceramics.
3. The findings may generate evidence on the clinical effectiveness and long-term behavior of two hybrid ceramic materials
4. The research will provide long-term clinical data on modern dental materials, which is valuable for developing future materials and techniques.
5. The study evaluates how the properties of Beautilink SA self-adhesive resin cement interact with these crown materials to affect clinical outcomes, offering new insights into optimal cementation protocols.

Desired Public Benefits

1. Providing evidence-based guidance for dental practitioners regarding different hybrid ceramic blocks.
2. Providing clinicians with evidence-based guidance for selecting the most suitable hybrid ceramic material for full coverage crowns in the esthetic zone.
3. Enhancing the longevity of restorations by identifying bonding protocols less prone to debonding, which is identified as one of the most common failure modes.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karim A Awadallah, MSC, PhD; Phone Number: +201006247666; Email: karimawadallah@dentistry.cu.edu.eg
• Study Contact Backup: Name: Omnia Nabil, MSC, PhD; Phone Number: +201222201179; Email: omnianabil84@hotmail.com

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt
      • Recruiting
      • Faculty of Dentistry, Cairo University
      • Contact: Reham Elbasty, MSC, PhD; Phone Number: +201207169671; Email: reham.elbasty@dentistry.cu.edu.eg
      • Principal Investigator: KARIM A Awadallah, MSC, PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vita Enamic Hybrid Ceramic full coverage Crowns; Polymer-infiltrated-ceramic-network material (Vita Enamic)	Other: Shofu HC Hard full coverage corwns; HC HARD hybrid ceramic crowns
Experimental: Shofu Hard HC full coverage crowns; highly esthetic ceramic-based restorative (hybrid ceramics) for milling into dental restorations using a dental CAD/CAM system.	Other: Vita Enamic full coverage crowns; hybrid cermaics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color match	measurement of any mismatch in the color or translucency using Modified USPHS criteria	from enrollment to the end of treatment at 18 months

Collaborators and Investigators

• Sponsor: Karim Ahmed Awadallah Osman
• Investigators: Study Director: Reham Elbasty, MSC, PhD, Cairo University

Publications and helpful links

General Publications

• 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.)

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2025
• Primary Completion (Actual): November 10, 2025
• Study Completion (Estimated): May 10, 2026

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: clinical outcome- hybrid ceramics- resin cements; full coverage- marginal discrepancy
• Other Study ID Numbers: CEBD-CU-2025-05-26

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