Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.

NCT ID: NCT04023357

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endodontically Treated Teeth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PEEK

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.

Group Type EXPERIMENTAL

PEEK

Intervention Type OTHER

New polyetheretherketones material

Emax

lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns

Group Type ACTIVE_COMPARATOR

Emax

Intervention Type OTHER

standard etchable glass ceramic used for Endocrowns

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PEEK

New polyetheretherketones material

Intervention Type OTHER

Emax

standard etchable glass ceramic used for Endocrowns

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BioHPP polyetheretherketones lithium disilicate glass ceramic

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed mohamed osman Youssef

Internal resident faculty of oral & dental medicine Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed Youssef, M.D.S

Role: CONTACT

01064019439

Omaima Elmahlawy

Role: CONTACT

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26110927 (View on PubMed)

Zoidis 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.

Reference Type BACKGROUND
PMID: 27692583 (View on PubMed)

Sevimli 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.

Reference Type BACKGROUND
PMID: 28955538 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

emax_peek

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endodontic Posts Using the CAD/CAM Digital Method.
NCT07297108 ACTIVE_NOT_RECRUITING NA