Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
Sponsors
Source
Cairo University
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Not yet recruiting
Start Date
2019-11-01
Completion Date
2020-12-01
Primary Completion Date
2019-12-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
evaluation of marginal gap |
through study completion, an average of 1 year |
Secondary Outcome
Measure |
Time Frame |
|
Clinical evaluation of marginal adaptation |
1 Year |
|
Clinical evaluation of fracture resistance |
1 Year |
Enrollment
22
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
New polyetheretherketones material
Arm Group Label
PEEK
Other Name
BioHPP polyetheretherketones
Intervention Type
Other
Intervention Name
Description
standard etchable glass ceramic used for Endocrowns
Arm Group Label
Emax
Other Name
lithium disilicate glass ceramic
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
Gender
All
Minimum Age
18 Years
Maximum Age
60 Years
Healthy Volunteers
No
Overall Contact
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Cairo University
Investigator Full Name
Ahmed mohamed osman Youssef
Investigator Title
Internal resident faculty of oral & dental medicine Cairo University
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Lithium Carbonate
Arm Group
Arm Group Label
PEEK
Arm Group Type
Experimental
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 Group Label
Emax
Arm Group Type
Active Comparator
Description
lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Omaima Elmahlawy
Reference
Citation
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.
PMID
26110927
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.
PMID
27692583
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.
PMID
28955538
Other Outcome
Measure
Clinical evaluation of Retention
Time Frame
1 Year
Description
Retention of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Study First Submitted
July 15, 2019
Study First Submitted Qc
July 16, 2019
Study First Posted
July 17, 2019
Last Update Submitted
August 6, 2019
Last Update Submitted Qc
August 6, 2019
Last Update Posted
August 8, 2019
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.