One Year Clinical Evaluation of Milled BioHPP (PEEK) Versus Zirconia Veneered Single Crowns (RCT-one-year Evaluation).
Primary Purpose
Carious Tooth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BioHPP PEEK
Sponsored by
About this trial
This is an interventional treatment trial for Carious Tooth
Eligibility Criteria
Inclusion Criteria:
- From 18-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to withstand conventional dental procedures
- Patients with teeth problems indicated for single posterior crowns: (Badly decayed teeth / Teeth restored with large filling restorations / Endodontically treated teeth / Malformed teeth / Malposed teeth (Tilted, over-erupted, rotated, etc.) / Spacing between posterior teeth)
- Able to return for follow-up examinations and evaluation.
Exclusion Criteria:
- Patient less than 18 or more than 50 years
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
- Lack of opposing dentition in the area of interest
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
zirconia veneered crowns
milled BioHpp PEEK
Arm Description
we will use zirconia veneered single crowns as a control to evaluate the marginal integrity and fracture and patient satisfaction
we will use milled BioHPP PEEK single crowns as a intervention to evaluate the marginal integrity and fracture and patient satisfaction
Outcomes
Primary Outcome Measures
fracture
number of fracture
Secondary Outcome Measures
marginal interity
marginal gap at the finish line
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03701178
Brief Title
One Year Clinical Evaluation of Milled BioHPP (PEEK) Versus Zirconia Veneered Single Crowns (RCT-one-year Evaluation).
Official Title
One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK) Versus Zirconia Veneered Single Crowns (Randomized Controlled Clinical Trial-one-year Evaluation).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. Long term success of all ceramic crowns is affected by many factors. Fracture of the all ceramic crowns is the most repeated failure pattern and represents about 67% of total failures associated with this type of restoration through a period of 15 years of clinical performance.
Polyetheretherketone (PEEK) is a polymer that has many potentials uses in dentistry. Polyetheretherketone (PEEK) can be used to support fixed dental prostheses. However, information about physio mechanical characterization is still scarce.
Detailed Description
Polyetheretherketone (PEEK) is a synthetic, tooth colored polymeric material that has been used as a biomaterial in orthopedics for many years due to its lower Young's (elastic) modulus (3-4 GPa) being close to human bone. PEEK can be modified easily by incorporation of other materials. For example; incorporation of carbon fibers or glass fibers can increase the elastic modulus up to 18 GPa which becomes comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution . Moreover, tensile properties of PEEK are also analogous to those of bone, enamel and dentin making it a suitable restorative material as far as the mechanical properties are concerned.
BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.
BioHPP PEEK can be fabricated via CAD/CAM technology by milling PEEK blanks. It is also can be pressed by using granular or pellet-shaped PEEK. Three-unit PEEK fixed partial denture manufactured via CAD-CAM has been suggested to have a higher fracture resistance than pressed granular- or pellet-shaped PEEK dentures.
The fracture resistance of the CAD/CAM milled PEEK fixed dentures is much higher than those of lithium disilicate glass-ceramic (950N), alumina (851N) , zirconia (981-1331N). The abrasive properties of PEEK are excellent. Despite of significantly low elastic moduli and hardness, abrasive resistance of PEEK is competitive with metallic alloys .
BioHPP PEEK can be used under resin composite as a coping material. Because the mechanical properties of PEEK are similar to those of dentin and enamel, PEEK could have an advantage over alloy and ceramic restorations . A variety of procedures have been suggested to condition the surface of PEEK in order to facilitate its bonding with resin composite crowns. For example, air abrasion with and without silica coating creates a more wettable surface. Etching with sulphuric acid creates a rough and chemically altered surface which enables it to bond more effectively with hydrophobic resin composites .
Due to these unique physical and mechanical properties, BioHPP PEEK is a promising material for dental application and it has been proposed for other prosthodontic applications such as fixed prostheses and removable prostheses .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
zirconia veneered crowns
Arm Type
Active Comparator
Arm Description
we will use zirconia veneered single crowns as a control to evaluate the marginal integrity and fracture and patient satisfaction
Arm Title
milled BioHpp PEEK
Arm Type
Experimental
Arm Description
we will use milled BioHPP PEEK single crowns as a intervention to evaluate the marginal integrity and fracture and patient satisfaction
Intervention Type
Other
Intervention Name(s)
BioHPP PEEK
Intervention Description
milled BioHPP PEEK in a new material can be used as a dental restoration
Primary Outcome Measure Information:
Title
fracture
Description
number of fracture
Time Frame
1 year
Secondary Outcome Measure Information:
Title
marginal interity
Description
marginal gap at the finish line
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
patient satisfaction
Description
patient satisfy from the color and anatomy of the restoration
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
From 18-50 years old, be able to read and sign the informed consent document.
Have no active periodontal or pulpal diseases, have teeth with good restorations
Psychologically and physically able to withstand conventional dental procedures
Patients with teeth problems indicated for single posterior crowns: (Badly decayed teeth / Teeth restored with large filling restorations / Endodontically treated teeth / Malformed teeth / Malposed teeth (Tilted, over-erupted, rotated, etc.) / Spacing between posterior teeth)
Able to return for follow-up examinations and evaluation.
Exclusion Criteria:
Patient less than 18 or more than 50 years
Patient with active resistant periodontal diseases
Patients with poor oral hygiene and uncooperative patients
Pregnant women
Patients in the growth stage with partially erupted teeth
Psychiatric problems or unrealistic expectations
Lack of opposing dentition in the area of interest
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
abdelrahman mustafa, M.D.s
Phone
01024884480
Email
dr_lamina_propria@windowslive.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lamia Sayed, Professor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abdelrahman M el sokkary, mastrer
Organizational Affiliation
researcher
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
One Year Clinical Evaluation of Milled BioHPP (PEEK) Versus Zirconia Veneered Single Crowns (RCT-one-year Evaluation).
We'll reach out to this number within 24 hrs