Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
Primary Purpose
Endodontically Treated Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEEK
Emax
Sponsored by
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PEEK
Emax
Arm Description
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.
lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns
Outcomes
Primary Outcome Measures
evaluation of marginal gap
Marginal gap of the restorations assessed by Silicon replica technique using digital microscope
Secondary Outcome Measures
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04023357
Brief Title
Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
Official Title
Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEEK
Arm Type
Experimental
Arm Description
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.
Arm Title
Emax
Arm Type
Active Comparator
Arm Description
lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns
Intervention Type
Other
Intervention Name(s)
PEEK
Other Intervention Name(s)
BioHPP polyetheretherketones
Intervention Description
New polyetheretherketones material
Intervention Type
Other
Intervention Name(s)
Emax
Other Intervention Name(s)
lithium disilicate glass ceramic
Intervention Description
standard etchable glass ceramic used for Endocrowns
Primary Outcome Measure Information:
Title
evaluation of marginal gap
Description
Marginal gap of the restorations assessed by Silicon replica technique using digital microscope
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Clinical evaluation of marginal adaptation
Description
Marginal adaptation of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
Time Frame
1 Year
Title
Clinical evaluation of fracture resistance
Description
Fracture resistance of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
Time Frame
1 Year
Other Pre-specified Outcome Measures:
Title
Clinical evaluation of Retention
Description
Retention of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Youssef, M.D.S
Phone
01064019439
Email
Ahmedmohamedosman90@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Omaima Elmahlawy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26110927
Citation
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.
Results Reference
background
PubMed Identifier
27692583
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.
Results Reference
background
PubMed Identifier
28955538
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.
Results Reference
background
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Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
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