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

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04023357
• Other study ID #: emax_peek
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: Ahmed Youssef, M.D.S
• Phone: 01064019439
• Email: Ahmedmohamedosman90[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

Other:
• PEEK
New polyetheretherketones material
• Emax
standard etchable glass ceramic used for Endocrowns

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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