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NCT Number: NCT07264491

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

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Of Dentistry, Cairo University

Cairo, Manial, Egypt

Location status: Recruiting

Location contact

KARIM A Awadallah, MSC, PhD

PRINCIPAL_INVESTIGATOR

Reham Elbasty, MSC, PhD

CONTACT

[email protected]

+201207169671

About this study

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

  • This research will help understanding the material-specific outcomes in terms of marginal adaptation, color match, retention, surface texture, and restoration failure
  • The study will contribute to the understanding of the relationship between laboratory findings and clinical outcomes for dental materials, particularly regarding hybrid ceramics.
  • The findings may generate evidence on the clinical effectiveness and long-term behavior of two hybrid ceramic materials
  • The research will provide long-term clinical data on modern dental materials, which is valuable for developing future materials and techniques.
  • 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

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Shofu HC Hard full coverage corwns

Other

HC HARD hybrid ceramic crowns

Vita Enamic full coverage crowns

Other

hybrid cermaics

Primary outcomes

  1. marginal adaptation

    Time frame: from enrollment to the end of treatment at 18 months

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

Secondary outcomes

  1. Color match

    Time frame: from enrollment to the end of treatment at 18 months

    measurement of any mismatch in the color or translucency using Modified USPHS criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Karim A Awadallah, MSC, PhD

CONTACT

[email protected]

+201006247666

Omnia Nabil, MSC, PhD

CONTACT

[email protected]

+201222201179

Sponsors and collaborators

Lead sponsor

Karim Ahmed Awadallah Osman

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 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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