Clinical PerformanceNCT05337358
Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).
A study testing endocrown in people with Clinical Performance, run by Cairo University at 1 site in Egypt.
Trial summary
In patients with endodontically treated molar teeth indicated for endocrown, will the fiber reinforced FRC base and bonded CAD/CAM resin composite endocrowns restorations have a similar clinical performance to the conventional lithium disilicate endocrown over one year? Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Performance
- What is being tested?
- endocrown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 11 Apr 2023
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with good oral hygiene
- Patients having one or more endodontically treated molars that need prosthetic restoration.
- Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
- Fully erupted molars
- Molars free of developmental defect
- Healthy periodontium
- Absence of periapical pathosis
- Acceptable endodontic treatment and proper bone support
Who cannot join
- Patients with bad oral hygiene
- Patients with active periodontal disease
- Patients with missing teeth opposing to the area intended for restoration
- Patients with parafunctional habits or psychiatric problems or unrealistic expectation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Sameh Sh Abou-steit, 01001891010, samehabousteit@gmail.com
About this study
In patients with endodontically treated molar teeth indicated for endocrown, will the fiber reinforced FRC base and bonded CAD/CAM resin composite endocrowns restorations have a similar clinical performance to the conventional lithium disilicate endocrown over one year?
- Conditions
- Clinical Performance
- Being tested
- endocrown
- Keywords
- Lithium dislocate, fiber reinforced composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocrownProcedure or surgery
endocrown
| Study group | Role | What they receive |
|---|---|---|
| Lithium disilicate | Active comparator | The intervention will be: Prosthetic endocrown Receives: Procedure: endocrown |
| Fiber reinforced composite | Active comparator | The intervention will be: Prosthetic endocrown Receives: Procedure: endocrown |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance
Using the modified United States Public Health Service criteria (Modified USPHS)- categorical
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Apr 2021
- Primary completion11 Apr 2023 (estimated)
- Study completion11 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PerformanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abou-steit, Cairo University
- Investigators
- Sameh Sh Abou-steit, PhD, Principal investigator, Lecturer of Fixed Prosthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337358
- Sponsor's protocol ID
- CEBD-2021-3-040
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).
- ClinicalTrials.gov ID
- NCT05337358
- Acronym / sponsor ID
- CEBD-2021-3-040
- Conditions
- Clinical Performance
- Keywords
- Lithium dislocate, fiber reinforced composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 11 Apr 2023 (estimated)
- Study completion
- 11 Apr 2023 (estimated)
- First posted
- 20 Apr 2022 (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.
In patients with endodontically treated molar teeth indicated for endocrown, will the fiber reinforced FRC base and bonded CAD/CAM resin composite endocrowns restorations have a similar clinical performance to the conventional lithium disilicate endocrown over one year?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium disilicate | Active comparator | Procedure: endocrownThe intervention will be: Prosthetic endocrown |
| Fiber reinforced composite | Active comparator | Procedure: endocrownThe intervention will be: Prosthetic endocrown |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with good oral hygiene
- Patients having one or more endodontically treated molars that need prosthetic restoration.
- Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
- Fully erupted molars
- Molars free of developmental defect
Key exclusion criteria (4 listed)
- Patients with bad oral hygiene
- Patients with active periodontal disease
- Patients with missing teeth opposing to the area intended for restoration
- Patients with parafunctional habits or psychiatric problems or unrealistic expectation.
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 |
|---|---|---|
| endocrownendocrown | Procedure or surgery | Fiber reinforced composite, Lithium disilicate |
Primary outcome
clinical performance
Time frame: 2 years
Using the modified United States Public Health Service criteria (Modified USPHS)- categorical
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Sameh Sh Abou-steit, PhD principal investigator
Lecturer of Fixed Prosthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endocrown in people with Clinical Performance, 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameh Sh Abou-steit, PhD (01001891010 ext. +2, samehabousteit@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical performance (time frame: 2 years). 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 20 Apr 2022.