Dental Restoration Failure of Marginal IntegrityNCT07264491
Clinical Performance of Full Coverage Hybrid Ceramic Crowns in the Aesthetic Zone: A Randomized Clinical Trial
A study testing Shofu HC Hard full coverage corwns and Vita Enamic full coverage crowns in people with Dental Restoration Failure of Marginal Integrity and Poor Aesthetic of Existing Restoration of Tooth, run by Karim Ahmed Awadallah Osman at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure of Marginal Integrity, Poor Aesthetic of Existing Restoration of Tooth
- What is being tested?
- Shofu HC Hard full coverage corwns and Vita Enamic full coverage crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2025to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Dentistry, Cairo University
Cairo, Manial
Reham Elbasty, MSC, PhD, +201207169671, reham.elbasty@dentistry.cu.edu.eg
KARIM A Awadallah, MSC, PhD
About this study
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
Read the 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
- 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.
- Conditions
- Dental Restoration Failure of Marginal Integrity, Poor Aesthetic of Existing Restoration of Tooth
- Being tested
- Shofu HC Hard full coverage corwns, Vita Enamic full coverage crowns
- Keywords
- clinical outcome- hybrid ceramics- resin cements, full coverage- marginal discrepancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shofu HC Hard full coverage corwnsOther
HC HARD hybrid ceramic crowns
Vita Enamic full coverage crownsOther
hybrid cermaics
| Study group | Role | What they receive |
|---|---|---|
| Vita Enamic Hybrid Ceramic full coverage Crowns | Active comparator | Polymer-infiltrated-ceramic-network material (Vita Enamic) Receives: Other: Shofu HC Hard full coverage corwns |
| Shofu Hard HC full coverage crowns | Experimental | highly esthetic ceramic-based restorative (hybrid ceramics) for milling into dental restorations using a dental CAD/CAM system. Receives: Other: Vita Enamic full coverage crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal adaptation
measurement of vertical and horizontal discrepancies at the margins of dental restorations
Measured: from enrollment to the end of treatment at 18 months
Secondary outcomes (1)
Color match
measurement of any mismatch in the color or translucency using Modified USPHS criteria
Measured: from enrollment to the end of treatment at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start20 Sep 2025
- Primary completion10 Nov 2025
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Restoration Failure of Marginal IntegrityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Model Description
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karim Ahmed Awadallah Osman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karim Ahmed Awadallah Osman, Cairo University
- Investigators
- Reham Elbasty, MSC, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264491
- Sponsor's protocol ID
- CEBD-CU-2025-05-26
- Status last verified
- Dec 2025
- First submitted
- 11 Jun 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16950933
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Full Coverage Hybrid Ceramic Crowns in the Aesthetic Zone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07264491
- Acronym / sponsor ID
- CEBD-CU-2025-05-26
- Conditions
- Dental Restoration Failure of Marginal Integrity, Poor Aesthetic of Existing Restoration of Tooth
- Keywords
- clinical outcome- hybrid ceramics- resin cements, full coverage- marginal discrepancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Karim Ahmed Awadallah OsmanUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Vita Enamic Hybrid Ceramic full coverage Crowns | Active comparator | Other: Shofu HC Hard full coverage corwnsPolymer-infiltrated-ceramic-network material (Vita Enamic) |
| Shofu Hard HC full coverage crowns | Experimental | Other: Vita Enamic full coverage crownshighly esthetic ceramic-based restorative (hybrid ceramics) for milling into dental restorations using a dental CAD/CAM system. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shofu HC Hard full coverage corwnsHC HARD hybrid ceramic crowns | Other | Vita Enamic Hybrid Ceramic full coverage Crowns |
| Vita Enamic full coverage crownshybrid cermaics | Other | Shofu Hard HC full coverage crowns |
Primary outcome
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
1 secondary outcome
Color match
Time frame: from enrollment to the end of treatment at 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 16950933Giordano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reham Elbasty, MSC, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shofu HC Hard full coverage corwns and Vita Enamic full coverage crowns in people with Dental Restoration Failure of Marginal Integrity and Poor Aesthetic of Existing Restoration of Tooth, run by Karim Ahmed Awadallah Osman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim A Awadallah, MSC, PhD (+201006247666, karimawadallah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal adaptation (time frame: from enrollment to the end of treatment at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07264491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.