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Recruiting NCT07264491

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

No phase Interventional Dental Restoration Failure of Marginal Integrity Poor Aesthetic of Existing Restoration of Tooth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shofu HC Hard full coverage corwns, Vita Enamic full coverage crowns.
Who it may be relevant to
Registry conditions: Dental Restoration Failure of Marginal Integrity, Poor Aesthetic of Existing Restoration of Tooth. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Shofu HC Hard full coverage corwns
    HC HARD hybrid ceramic crowns
  • Other Vita Enamic full coverage crowns
    hybrid cermaics

Primary outcome measures

  • marginal adaptation [Time frame: from enrollment to the end of treatment at 18 months]
Secondary outcome measures (1)
  • Color match [Time frame: from enrollment to the end of treatment at 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty Of Dentistry, Cairo University — Cairo

Publications

  • Giordano R. Materials for chairside CAD/CAM-produced restorations. J Am Dent Assoc. 2006 Sep;137 Suppl:14S-21S. doi: 10.14219/jada.archive.2006.0397. PMID 16950933

Identifiers

NCT: NCT07264491 · CEBD-CU-2025-05-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗