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

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 Overview

• Status: Unknown
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Other: PEEK; Other: Emax

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Youssef, M.D.S; Phone Number: 01064019439; Email: Ahmedmohamedosman90@gmail.com
• Study Contact Backup: Name: Omaima Elmahlawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: PEEK; New polyetheretherketones material; Other Names: BioHPP polyetheretherketones
ACTIVE_COMPARATOR: Emax; lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns	Other: Emax; standard etchable glass ceramic used for Endocrowns; Other Names: lithium disilicate glass ceramic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of marginal gap	Marginal gap of the restorations assessed by Silicon replica technique using digital microscope	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	1 Year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evaluation of Retention	Retention of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)	1 Year

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (ACTUAL): July 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: emax_peek

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No