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

NCT ID: NCT07264491

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-20
• Study Completion Date: 2026-05-10

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vita Enamic Hybrid Ceramic full coverage Crowns

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

Group Type: ACTIVE_COMPARATOR

Shofu HC Hard full coverage corwns

Intervention Type: OTHER

HC HARD hybrid ceramic crowns

Shofu Hard HC full coverage crowns

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

Group Type: EXPERIMENTAL

Vita Enamic full coverage crowns

Intervention Type: OTHER

hybrid cermaics

Interventions

Shofu HC Hard full coverage corwns

HC HARD hybrid ceramic crowns

Intervention Type: OTHER

Vita Enamic full coverage crowns

hybrid cermaics

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karim Ahmed Awadallah Osman

OTHER

Sponsor Role: lead

Responsible Party

Karim Ahmed Awadallah Osman

Lecturer, Fixed Prosthodontics Department, Faculty of Dentistry, Cairo University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Reham Elbasty, MSC, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty Of Dentistry, Cairo University

Cairo, Manial, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Karim A Awadallah, MSC, PhD

Role: CONTACT

karimawadallah@dentistry.cu.edu.eg

+201006247666

Omnia Nabil, MSC, PhD

Role: CONTACT

omnianabil84@hotmail.com

+201222201179

Facility Contacts

Reham Elbasty, MSC, PhD

Role: primary

reham.elbasty@dentistry.cu.edu.eg

+201207169671

References

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.)

Reference Type: BACKGROUND

Other Identifiers

CEBD-CU-2025-05-26

Identifier Type: -

Identifier Source: org_study_id