- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07508475
Clinical Assessment of CAD/CAM Fabricated Lithium-Disilicate Overlay Versus Lithium-disilicate Endocrowns for Restoration of Endodontically Treated Teeth.
March 31, 2026 updated by: Moataz Abd ElHalem, Cairo University
Clinical Assessment of CAD/CAM Fabricated Lithium-Disilicate Overlay Versus Lithium-disilicate Endocrowns for Restoration of Endodontically Treated Teeth. A Randomized Controlled Clinical Study
A Randomized Controlled Clinical Study aims for Clinical Assessment of CAD/CAM Fabricated Lithium-Disilicate overlay in comparison to Lithium-disilicate Endocrowns for Restoration of Endodontically Treated Teeth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Investigators are going to compare the clinical behavior of the lithium disilicate overlay as a more conservative line of treatment for endodontic treated teeth.
overlays will be compared to the lithium disilicate endocrowns .primary
outcome will be marginal adaptation ,secondary outcomes will be survival and patient satisfaction .
Baseline, 5, 10, 15, and 20 months follow up will extend to 20 months(Baseline, 5, 10, 15, and 20 months) .This is a randomized, controlled, parallel-group clinical trial with 1:1 allocation ratio.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 12567
- Faculty of Dentistry Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients with endodontically treated teeth indicated to ceramic Endocrowns.
- Patients with endodontically treated teeth indicated to ceramic overlays.
- Physically and psychologically able to tolerate conventional restorative procedures.
- Have no active periodontal or periapical diseases.
- Maintenance of good oral hygiene.
- Willing to return for follow-up examinations and evaluation.
Exclusion Criteria:
- Patients in the growth stage with partially erupted teeth.
- Patients with para-functional habits.
- Patients with defective endodontic treatment.
- Patients with poor oral hygiene and motivation.
- Psychiatric problems or unrealistic expectations.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: lithium disilicate endocrown
|
indirect partial coverage restoration that cover mainly the occlusal surface of posterior teeth
Other Names:
|
|
Active Comparator: overlay
|
indirect partial coverage restoration that cover mainly the occlusal surface of posterior teeth
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
marginal adaptations
Time Frame: Baseline, 5 months, 10 months, 15 months, and 20 months
|
Marginal adaptation will be evaluated using Modified United States Public Health Service (USPHS) criteria by two calibrated independent examiners.
Scores will be recorded as Alpha, Bravo, or Charlie based on marginal integrity.
|
Baseline, 5 months, 10 months, 15 months, and 20 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
marginal discoloration
Time Frame: Baseline, 5, 10, 15, and 20 months
|
change in margins colour as a result of leakage , Assessed using Modified USPHS criteria as Alpha, Bravo, or Charlie scores.
|
Baseline, 5, 10, 15, and 20 months
|
|
patient satisfaction
Time Frame: 20 months
|
patient acceptance to the treatment
|
20 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Actual)
March 1, 2024
Study Completion (Actual)
March 15, 2024
Study Registration Dates
First Submitted
March 9, 2026
First Submitted That Met QC Criteria
March 31, 2026
First Posted (Actual)
April 2, 2026
Study Record Updates
Last Update Posted (Actual)
April 2, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Theme 3,Objective FPD 3-2-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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