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Clinical Trials/NCT04023357
NCT04023357UnknownNot Applicable

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

Cairo University0 sites22 target enrollmentStarted: November 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
22
Primary Endpoint
evaluation of marginal gap

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
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

Arms & Interventions

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.

Intervention: PEEK (Other)

Emax

Active Comparator

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

Intervention: Emax (Other)

Outcomes

Primary Outcomes

evaluation of marginal gap

Time Frame: through study completion, an average of 1 year

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

Secondary Outcomes

  • Clinical evaluation of fracture resistance(1 Year)
  • Clinical evaluation of marginal adaptation(1 Year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed mohamed osman Youssef

Internal resident faculty of oral & dental medicine Cairo University

Cairo University

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