Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
ID07264491

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

Led by Karim Ahmed Awadallah Osman · Updated on 2025-12-04

54

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical performance of full coverage hybrid ceramic crowns in the aesthetic zone for adults aged 21 years and older. This randomized clinical trial aims to compare two types of hybrid ceramic materials, Vita Enamic and Shofu HC Hard crowns, to understand their long-term behavior, marginal adaptation, color matching, retention, and surface texture. The study also examines how the properties of Beautilink SA self-adhesive resin cement affect these crowns' clinical outcomes, contributing valuable data for future dental material development and treatment protocols. Participants will receive high-quality dental restorations made from hybrid ceramic materials using a dental CAD/CAM system. Qualified dental professionals will place the crowns in a controlled clinical setting, ensuring proper technique and care. The study includes regular follow-up visits at 6, 12, and 18 months to monitor the restorations and detect any issues early. Any failures will be documented and repaired at no cost to participants, while the research will also monitor overall oral health during the study. During the study, participants will undergo detailed dental evaluations including checks for marginal adaptation and color match of the restorations from enrollment through 18 months. The study tracks clinical outcomes such as restoration failure and bonding quality. Participants will have periodic follow-up recalls to assess their dental restorations, receive repairs if needed, and help advance knowledge about the tested materials. This comprehensive monitoring aims to improve future dental treatment outcomes and material choices.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients requiring full coverage crowns in the aesthetic zone
  • Age 21 years or older
  • Teeth may be vital or endodontically treated
  • Willing and able to provide written informed consent
  • Ability to attend all follow-up appointments
  • Adequate oral hygiene as determined by the investigator
Not Eligible

You will not qualify if you...

  • Active periodontal disease with probing depth greater than 4mm or bleeding on probing
  • Parafunctional habits such as bruxism confirmed by clinical examination
  • Poor oral hygiene with plaque index above 30%
  • Systemic diseases affecting treatment outcomes such as uncontrolled diabetes or immunosuppression
  • Known allergies to ceramic materials or resin cement components
  • Inability to comply with study requirements
  • Current participation in other dental clinical trials

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 18 months

Participants receive full coverage hybrid ceramic crowns placed by qualified dental professionals using standardized protocols and materials.

Baseline visit for crown placement and follow-up visits at 6, 12, and 18 months

Trial Site Locations

Total: 1 location

1

Faculty Of Dentistry, Cairo University

Cairo, Manial, Egypt

Actively Recruiting

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Research Team

K

Karim A Awadallah, MSC, PhD

O

Omnia Nabil, MSC, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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