Back to resultsStability, Marginal Bone Loss and Occlusal Load Analysis of PEEK Abutment Supported on Short Implant
Primary Purpose
Marginal Bone Loss and Loss of Osteointegration of Short Implant
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
customization of abutment
Sponsored by
About this trial
This is an interventional prevention trial for Marginal Bone Loss and Loss of Osteointegration of Short Implant
Eligibility Criteria
Inclusion Criteria:
- 1. Age range of patients 30-45 years old, with no gender prediction, able to read and sign the informed consent. 2. Patient with missing posterior tooth indicated for replacement with short implant as there are any anatomical limitation (near maxillary sinus or inferior alveolar nerve) or atrophic ridge. 3. Opposing natural teeth should be present. 4. The edentulous ridge should be free from any infection or remining root. 5. Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically. 6. Patient should be willing to return for follow-up examination and evaluation.
Exclusion Criteria:
- 1. Patients with active periodontal diseases. 2. Patient with poor oral hygiene and motivation. 3. Pregnant women. 4. Patient with unrealistic expectations. 5. Patients with parafunctional habits and smoker. 6. Patient with systemic disease and immunocompromised patients which will prevent surgical procedure. 7. Recent extraction or extraction socket with infection or remining root.
Sites / Locations
- Alazhar University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Customized PEEK abutment/ crown on a Ti base.
Prefabricated titanium abutment, supporting ceramometal separate crown.
Arm Description
Outcomes
Primary Outcome Measures
decrease marginal bone loss around short implant
Secondary Outcome Measures
Full Information
NCT ID
NCT04972240
First Posted
July 15, 2021
Last Updated
July 28, 2021
Sponsor
Faculty of Dental Medicine for Girls
1. Study Identification
Unique Protocol Identification Number
NCT04972240
Brief Title
Stability, Marginal Bone Loss and Occlusal Load Analysis of PEEK Abutment Supported on Short Implant
Official Title
Evaluation of Stability, Marginal Bone Loss and Occlusal Load Analysis of Customized Posterior Hybrid PEEK Abutments Supported by Short Implants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty of Dental Medicine for Girls
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
this study will be directed toward evaluating stability, marginal bone loss and occlusal load of posterior customized PEEK abutments on Ti-bases supported by short implant
Detailed Description
although short implant solved many clinical problems; it is sometimes associated with loss of osseointegration which is firstly expressed by peri-implantitis and marginal bone loss. Also, PEEK is a very promising material characterized by low modulus of elasticity thus it can act as a shock absorber. Whether constructing superstructure components of short implant from PEEK will improve their performance or not is lacking in the dental literature.
To conduct the present study, the following will be used:
Customized screw retained PEEK abutment/crown on a Ti base.
Prefabricated titanium abutment.
Short implant. The study will be conducted on 12 patients with missing single posterior tooth indicated for short implants) near anatomical structure or atrophic ridge), attending the outpatient clinic of the Crowns and Bridges department, Faculty of Dental Medicine for Girls, Al-Azhar University.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marginal Bone Loss and Loss of Osteointegration of Short Implant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Customized PEEK abutment/ crown on a Ti base.
Arm Type
Active Comparator
Arm Title
Prefabricated titanium abutment, supporting ceramometal separate crown.
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
customization of abutment
Intervention Description
we will customize abutment for every patient not ready made
Primary Outcome Measure Information:
Title
decrease marginal bone loss around short implant
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Age range of patients 30-45 years old, with no gender prediction, able to read and sign the informed consent. 2. Patient with missing posterior tooth indicated for replacement with short implant as there are any anatomical limitation (near maxillary sinus or inferior alveolar nerve) or atrophic ridge. 3. Opposing natural teeth should be present. 4. The edentulous ridge should be free from any infection or remining root. 5. Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically. 6. Patient should be willing to return for follow-up examination and evaluation.
Exclusion Criteria:
1. Patients with active periodontal diseases. 2. Patient with poor oral hygiene and motivation. 3. Pregnant women. 4. Patient with unrealistic expectations. 5. Patients with parafunctional habits and smoker. 6. Patient with systemic disease and immunocompromised patients which will prevent surgical procedure. 7. Recent extraction or extraction socket with infection or remining root.
Facility Information:
Facility Name
Alazhar University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Stability, Marginal Bone Loss and Occlusal Load Analysis of PEEK Abutment Supported on Short Implant
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