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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04023357
• Collaborator: (none)
• Enrollment: 22
• Arms: 2
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Endodontically Treated Teeth	Other: PEEK; Other: Emax	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
• Anticipated Study Start Date: Nov 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. evaluation of marginal gap [through study completion, an average of 1 year]

   Marginal gap of the restorations assessed by Silicon replica technique using digital microscope

Secondary Outcome Measures

1. Clinical evaluation of marginal adaptation [1 Year]

   Marginal adaptation of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)

2. Clinical evaluation of fracture resistance [1 Year]

   Fracture resistance of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)

Other Outcome Measures

1. Clinical evaluation of Retention [1 Year]

   Retention of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Otto T, Mörmann 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.
• 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. Review.
• 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.

• Responsible Party: Ahmed mohamed osman Youssef, Internal resident faculty of oral & dental medicine Cairo University, Cairo University
• ClinicalTrials.gov Identifier: NCT04023357
• Other Study ID Numbers: emax_peek
• First Posted: Jul 17, 2019
• Last Update Posted: Aug 8, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tooth, Nonvital

Study Results

No Results Posted as of Aug 8, 2019