Endodontically Treated TeethNCT04023357
Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
A study testing PEEK and Emax in people with Endodontically Treated Teeth, run by Cairo University.
Trial summary
Patients need Endocrowns for their teeth usually use Emax as an etchable ceramic. Yet they have disadvantages that may influence the outcome of the endocrowns, among which is the high stiffness and rigidity owing to the higher modulus of elasticity (67.2 GPa)( compared to natural dentin (18.6 GPa) which may affect the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- PEEK and Emax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Dec 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- All subjects are required to be:
- From 18-60 years old, and able to read and sign the informed consent document.
- Physically and psychologically able to tolerate conventional restorative procedures
- Have no active periodontal or pulpal diseases.
- Willing to return for follow-up examinations and evaluation
Who cannot join
- Patients in the growth stage with partially erupted teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women
- Psychiatric problems or unrealistic expectations
- Lack of opposite occluding dentition in the area intended for restoration
Trial locations and contacts
No sites are listed yet.
Omaima Elmahlawy contact
About this study
Patients need Endocrowns for their teeth usually use Emax as an etchable ceramic. Yet they have disadvantages that may influence the outcome of the endocrowns, among which is the high stiffness and rigidity owing to the higher modulus of elasticity (67.2 GPa)( compared to natural dentin (18.6 GPa) which may affect the marginal adaptation.so a less rigid material is needed. PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics, Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel.
.but the investigators have to know clinically it is performance , so the investigators are going to have Parallel groups in a randomized clinical trial.
- Conditions
- Endodontically Treated Teeth
- Being tested
- PEEK, Emax
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEKOther
Also called BioHPP polyetheretherketones
New polyetheretherketones material
EmaxOther
Also called lithium disilicate glass ceramic
standard etchable glass ceramic used for Endocrowns
| Study group | Role | What they receive |
|---|---|---|
| PEEK | Experimental | PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics,1 Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel.
Yet clinical studies are needed to evaluate their clinical performance. Receives: Other: PEEK |
| Emax | Active comparator | lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns Receives: Other: Emax |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of marginal gap
Marginal gap of the restorations assessed by Silicon replica technique using digital microscope
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Clinical evaluation of marginal adaptation
Marginal adaptation of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
Measured: 1 Year
Clinical evaluation of fracture resistance
Fracture resistance of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study startNov 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endodontically Treated TeethStudies 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed mohamed osman Youssef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023357
- Sponsor's protocol ID
- emax_peek
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Otto T, Mormann WH. Clinical performance of chairside CAD/CAM feldspathic ceramic posterior shoulder crowns and endocrowns up to 12 years. Int J Comput Dent. 2015;18(2):147-61. English, German.
PubMed 26110927Zoidis P, Bakiri E, Polyzois G. Using modified polyetheretherketone (PEEK) as an alternative material for endocrown restorations: A short-term clinical report. J Prosthet Dent. 2017 Mar;117(3):335-339. doi: 10.1016/j.prosdent.2016.08.009. Epub 2016 Sep 28.
PubMed 27692583Sevimli G, Cengiz S, Oruc MS. Endocrowns: review. J Istanb Univ Fac Dent. 2015 Apr 29;49(2):57-63. doi: 10.17096/jiufd.71363. eCollection 2015.
PubMed 28955538
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
- ClinicalTrials.gov ID
- NCT04023357
- Acronym / sponsor ID
- emax_peek
- Conditions
- Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Jul 2019 (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.
Patients need Endocrowns for their teeth usually use Emax as an etchable ceramic. Yet they have disadvantages that may influence the outcome of the endocrowns, among which is the high stiffness and rigidity owing to the higher modulus of elasticity (67.2 GPa)( compared to natural dentin (18.6 GPa) which may affect the marginal adaptation.so a less rigid material is needed. PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics, Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel.
.but the investigators have to know clinically it is performance , so the investigators are going to have Parallel groups in a randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK | Experimental | Other: PEEKPEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics,1 Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel. Yet clinical studies are needed to evaluate their clinical performance. |
| Emax | Active comparator | Other: Emaxlithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- From 18-60 years old, and able to read and sign the informed consent document.
- Physically and psychologically able to tolerate conventional restorative procedures
- Have no active periodontal or pulpal diseases.
- Willing to return for follow-up examinations and evaluation
Key exclusion criteria (6 listed)
- Patients in the growth stage with partially erupted teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women
- 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 |
|---|---|---|
| PEEKAlso: BioHPP polyetheretherketonesNew polyetheretherketones material | Other | PEEK |
| EmaxAlso: lithium disilicate glass ceramicstandard etchable glass ceramic used for Endocrowns | Other | Emax |
Primary outcome
evaluation of marginal gap
Time frame: through study completion, an average of 1 year
Marginal gap of the restorations assessed by Silicon replica technique using digital microscope
2 secondary outcomes
Clinical evaluation of marginal adaptation
Time frame: 1 Year
Clinical evaluation of fracture resistance
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Background: PubMed 26110927Otto T, Mormann WH. Clinical performance of chairside CAD/CAM feldspathic ceramic posterior shoulder crowns and endocrowns up to 12 years. Int J Comput Dent. 2015;18(2):147-61. English, German.
- Background: PubMed 27692583Zoidis P, Bakiri E, Polyzois G. Using modified polyetheretherketone (PEEK) as an alternative material for endocrown restorations: A short-term clinical report. J Prosthet Dent. 2017 Mar;117(3):335-339. doi: 10.1016/j.prosdent.2016.08.009. Epub 2016 Sep 28.
- Background: PubMed 28955538Sevimli G, Cengiz S, Oruc MS. Endocrowns: review. J Istanb Univ Fac Dent. 2015 Apr 29;49(2):57-63. doi: 10.17096/jiufd.71363. eCollection 2015.
- 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.
Omaima Elmahlawy contact
Questions about this trial
What is this clinical trial studying?
A study testing PEEK and Emax in people with Endodontically Treated Teeth, run by Cairo University.
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 5 inclusion and 6 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 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Youssef, M.D.S (01064019439, Ahmedmohamedosman90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of marginal gap (time frame: through study completion, an average of 1 year). 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 NCT04023357, which also lists 3 linked publications.
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 8 Aug 2019.