Nonvital ToothNCT07508475
Clinical Assessment of CAD/CAM Fabricated Lithium-Disilicate Overlay Versus Lithium-disilicate Endocrowns for Restoration of Endodontically Treated Teeth.
A study testing lithium disilicate overlays in people with Nonvital Tooth, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonvital Tooth
- What is being tested?
- lithium disilicate overlays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Cairo University
Cairo, Cairo Governorate, 12567
About this study
Official title: 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.
Read the 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.
- Conditions
- Nonvital Tooth
- Being tested
- lithium disilicate overlays
- Keywords
- Nonvital, Overlay, Endocrown, Ceramics
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithium disilicate overlaysOther
Also called occlusal veneer ,ceramic partial coverage
indirect partial coverage restoration that cover mainly the occlusal surface of posterior teeth
| Study group | Role | What they receive |
|---|---|---|
| lithium disilicate endocrown | Active comparator | Not described Receives: Other: lithium disilicate overlays |
| overlay | Active comparator | Not described Receives: Other: lithium disilicate overlays |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal adaptations
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.
Measured: Baseline, 5 months, 10 months, 15 months, and 20 months
Secondary outcomes (2)
marginal discoloration
change in margins colour as a result of leakage , Assessed using Modified USPHS criteria as Alpha, Bravo, or Charlie scores.
Measured: Baseline, 5, 10, 15, and 20 months
patient satisfaction
patient acceptance to the treatment
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Aug 2023
- Primary completion1 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonvital ToothStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahram Canadian University
- Responsible party
- Principal investigator, Moataz Abd ElHalem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508475
- Sponsor's protocol ID
- Theme 3,Objective FPD 3-2-2
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of CAD/CAM Fabricated Lithium-Disilicate Overlay Versus Lithium-disilicate Endocrowns for Restoration of Endodontically Treated Teeth. A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07508475
- Acronym / sponsor ID
- Theme 3,Objective FPD 3-2-2
- Conditions
- Nonvital Tooth
- Keywords
- Nonvital, Overlay, Endocrown, Ceramics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Ahram Canadian University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 2 Apr 2026 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lithium disilicate endocrown | Active comparator | Other: lithium disilicate overlays |
| overlay | Active comparator | Other: lithium disilicate overlays |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| lithium disilicate overlaysAlso: occlusal veneer ,ceramic partial coverageindirect partial coverage restoration that cover mainly the occlusal surface of posterior teeth | Other | lithium disilicate endocrown, overlay |
Primary outcome
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.
2 secondary outcomes
marginal discoloration
Time frame: Baseline, 5, 10, 15, and 20 months
patient satisfaction
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Nonvital Tooth
Active, not recruiting
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Endodontically Treated Teeth, Calcium Hydroxide
Not yet recruiting
Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth
Cairo University, Nonvital Tooth
Active, not recruiting
Clinical Comparison of Lithium Disilicate and 3D-Printed Resin Endocrowns
Endodontically Treated Teeth, Nonvital Teeth
Recruiting
Conservative Versus Conventional Restorative Approach for Endodontically Treated Posterior Teeth
Root Canal Treated Posterior Teeth, Endodontically-Treated Teeth
Not yet recruiting
Predictable Method for Restoring Endodontically Treated Teeth, Comparing Indirect and Direct Methods and Materials in Aesthetic Dentistry.
Endodontically Treated Teeth Requiring Indirect Restorative Treatment
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lithium disilicate overlays in people with Nonvital Tooth, run by Cairo University 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 5 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: finished, as of the sponsor's last update on 2 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal adaptations (time frame: Baseline, 5 months, 10 months, 15 months, and 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.