Endodontically Treated MolarPEEKNCT06500845
Assessment of Marginal and Internal Fit of High Performance Polymer PEEK Endocrown Using Two Preparation Designs
A study testing Bevel marginal design endocrown for endodontically treated teeth and Butt marginal design endocrown for endodontically treated teeth in people with Endodontically Treated Molar and Marginal Fit, run by Cairo University at 1 site in Egypt.
Trial summary
First, Participants in this study will be recruited according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for endodontically treated molar for receiving high performance polymer endocrown. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Molar, Marginal Fit, Internal Fit
- What is being tested?
- Bevel marginal design endocrown for endodontically treated teeth and Butt marginal design endocrown for endodontically treated teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2025to 1 Jun 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient age range from 18 years -50 years old. They should be able to read and write so they can sign the informed consent.
- Patient should have a good physical and psychologically state to be able to withstand the steps of the restoration procedure.
- Have a molar with root canal filling with no active periodontal or apical involvement.
- Patients having root canal treatment teeth indicated for endocrown treatment with 3 or 4 axial walls remaining.
- Patient with axial wall length not less than 3 mm and not more than 5 mm.
- Patient should have good oral hygiene and motivation.
Who cannot join
- Patient with periodontal or apical involvement or improper root canal treatment.
- Severe loss of the tooth structure in which the amount of the remaining tooth structure is less than 2mm.
- Patient with poor oral hygiene or with occlusal instability
- Patient with improper physical or psychological state.
- Patient not pregnant or lactating.
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
Cairo University
Cairo
Fatema K. Mansour, Assis. Lect., 01142212367, fatemakhaledmansour@gmail.com
Aisha K. Mansour, 01119755516, akmansour@msa.eun.eg
About this study
Official title: Assessment of Marginal and Internal Fit of High Performance Polymer Endocrown Using Two Preparation Designs (Randomized Clinical Trial)
First, Participants in this study will be recruited according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for endodontically treated molar for receiving high performance polymer endocrown. Checking and verification for the restoration (trying) and assessment of marginal and internal fit by replica technique. Then final cementation of endocrown.
Read the detailed description
Examination and diagnosis:
Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.
Primary alginate impressions for diagnosis on primary casts and for mounting. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.
Taking a professional pre-operative photo.
Tooth preparation procedure:
Preparation of endocrown with two preparation designs on endodontically treated molars.
After tooth preparation, the final impression will be taken for each participant using polyvinyl siloxane impression and temporization of cavity using light curable temporary material.
Restoration trial appointment:
Endocrown try in and assessment of marginal and internal fit using replica technique with light body rubber impression.
Fabrication of final restoration:
Delivery of high performance polymer endocrown will be fabricated according to the two preparation designs; butt and bevel.
- Conditions
- Endodontically Treated Molar, Marginal Fit, Internal Fit
- Being tested
- Bevel marginal design endocrown for endodontically treated teeth, Butt marginal design endocrown for endodontically treated teeth
- Keywords
- Endocrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevel marginal design endocrown for endodontically treated teethOther
Bevel marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown
Butt marginal design endocrown for endodontically treated teethOther
Butt marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Bevel marginal design endocrown for endodontically treated teeth Receives: Other: Bevel marginal design endocrown for endodontically treated teeth |
| Control group | Active comparator | Butt marginal design endocrown for endodontically treated teeth Receives: Other: Butt marginal design endocrown for endodontically treated teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal fit
stereomicroscope by Micrometer
Measured: 2 weeks
Secondary outcomes (1)
Internal fit
stereomicroscope by Micrometer
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start17 Sep 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated MolarStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatema Khaled Mohammed Mansour, Cairo University
- Investigators
- Fatema K. Mansour, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500845
- Sponsor's protocol ID
- 3324
- Acronym
- PEEK
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Marginal and Internal Fit of High Performance Polymer Endocrown Using Two Preparation Designs (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06500845
- Acronym / sponsor ID
- PEEK / 3324
- Conditions
- Endodontically Treated Molar, Marginal Fit, Internal Fit
- Keywords
- Endocrown
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Sep 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 15 Jul 2024 (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.
First, Participants in this study will be recruited according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for endodontically treated molar for receiving high performance polymer endocrown. Checking and verification for the restoration (trying) and assessment of marginal and internal fit by replica technique. Then final cementation of endocrown.
Detailed description
Examination and diagnosis:
Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.
Primary alginate impressions for diagnosis on primary casts and for mounting. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.
Taking a professional pre-operative photo.
Tooth preparation procedure:
Preparation of endocrown with two preparation designs on endodontically treated molars.
After tooth preparation, the final impression will be taken for each participant using polyvinyl siloxane impression and temporization of cavity using light curable temporary material.
Restoration trial appointment:
Endocrown try in and assessment of marginal and internal fit using replica technique with light body rubber impression.
Fabrication of final restoration:
Delivery of high performance polymer endocrown will be fabricated according to the two preparation designs; butt and bevel.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Bevel marginal design endocrown for endodontically treated teethBevel marginal design endocrown for endodontically treated teeth |
| Control group | Active comparator | Other: Butt marginal design endocrown for endodontically treated teethButt marginal design endocrown for endodontically treated teeth |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient age range from 18 years -50 years old. They should be able to read and write so they can sign the informed consent.
- Patient should have a good physical and psychologically state to be able to withstand the steps of the restoration procedure.
- Have a molar with root canal filling with no active periodontal or apical involvement.
- Patients having root canal treatment teeth indicated for endocrown treatment with 3 or 4 axial walls remaining.
- Patient with axial wall length not less than 3 mm and not more than 5 mm.
Key exclusion criteria (5 listed)
- Patient with periodontal or apical involvement or improper root canal treatment.
- Severe loss of the tooth structure in which the amount of the remaining tooth structure is less than 2mm.
- Patient with poor oral hygiene or with occlusal instability
- Patient with improper physical or psychological state.
- Patient not pregnant or lactating.
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 |
|---|---|---|
| Bevel marginal design endocrown for endodontically treated teethBevel marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown | Other | Intervention group |
| Butt marginal design endocrown for endodontically treated teethButt marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown | Other | Control group |
Primary outcome
Marginal fit
Time frame: 2 weeks
stereomicroscope by Micrometer
1 secondary outcome
Internal fit
Time frame: 2 weeks
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 19 Sep 2025.
- 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.
Fatema K. Mansour principal investigator
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 Bevel marginal design endocrown for endodontically treated teeth and Butt marginal design endocrown for endodontically treated teeth in people with Endodontically Treated Molar and Marginal Fit, 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: looking for participants now, as of the sponsor's last update on 19 Sep 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 Fatema K. Mansour, Assist Lect. (01142212367, fatemakhaledmansour@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal fit (time frame: 2 weeks). 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 19 Sep 2025.