NCT04023357

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

July 15, 2019

Last Update Submit

August 6, 2019

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Clinical evaluation of marginal adaptation

    1 Year

  • Clinical evaluation of fracture resistance

    1 Year

Other Outcomes (1)

  • Clinical evaluation of Retention

    1 Year

Study Arms (2)

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.

Other: PEEK

Emax

ACTIVE COMPARATOR

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

Other: Emax

Interventions

PEEKOTHER

New polyetheretherketones material

Also known as: BioHPP polyetheretherketones
PEEK
EmaxOTHER

standard etchable glass ceramic used for Endocrowns

Also known as: lithium disilicate glass ceramic
Emax

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26110927BACKGROUND

  • 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.

    PMID: 27692583BACKGROUND

  • 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.

    PMID: 28955538BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

polyetheretherketone

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Central Study Contacts

Ahmed Youssef, M.D.S

CONTACT

01064019439Ahmedmohamedosman90@gmail.com

Omaima Elmahlawy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal resident faculty of oral & dental medicine Cairo University

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

November 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

August 8, 2019

Record last verified: 2019-07