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Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.

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ClinicalTrials.gov Identifier: NCT03607006
Recruitment Status : Unknown
Verified July 2018 by Ola Alaa El-Din Abd El-Monem Mohamed, Cairo University.
Recruitment status was:  Recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Ola Alaa El-Din Abd El-Monem Mohamed, Cairo University

Study Description
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Brief Summary:
Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .

Condition or disease Intervention/treatment Phase
Ridge Deficiency Procedure: Patient specific PEEK sheets Procedure: Autogenous bone shell Not Applicable

Detailed Description:

A- Intervention Group (Patient specific PEEK sheets)

  • Preoperative Computed tomography will be done to the patients.
  • Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.
  • Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.
  • After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.
  • Wounds closure will be done.
  • CT scan will be done postoperative.
  • After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.

B- Control Group (Autogenous bone shell technique)

  • Preoperative Computed tomography will be done to the patients
  • Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.
  • The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1
  • The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.
  • Wounds closure will be done.
  • CT scan will be done.
  • After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • A randomized clinical trial.
  • Parallel group study.
  • A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University .
  • Equal randomization : participants with equal probabilities for intervention.
  • Positive controlled : Both groups receiving treatment.
Masking: None (Open Label)
Masking Description: None because the two interventions requires different preoperative preparations , both the participants and the investigator can't be blinded .
Primary Purpose: Treatment
Official Title: 3D Ridge Augmentation in the Anterior Maxillary Region Using Patient Specific Polyether Ether Ketone (PEEK) Sheets vs. Autogenous Bone Shell Technique. A Randomized Clinical Trial: Comparative Study
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Patient specific PEEK sheets
Patient specific PEEK sheets will be fixed with titanium screws and act as containment system for the mixed autogenous/xenogenic bone graft that will fill the gap between the sheets and the ridge .
 Procedure: Patient specific PEEK sheets
Computer aided sheet design
Active Comparator: Autogenous bone shell technique
Bone shells will be fixed with titanium screws to the ridge and mixed autogenous/xenogenic bone graft will fill the gap between the shells and the ridge .
 Procedure: Autogenous bone shell
autogenous retromolar/chin bone graft


Outcome Measures
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Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 8 months ]
    Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)


Secondary Outcome Measures :
  1. Bone gain [ Time Frame: 4-6 months post-operative ]
    Bone gain will be evaluated using the Computed tomography , measuring unit (mm)

  2. Bone quality [ Time Frame: 4-6 months post-operative ]
    Histological analysis of bone core biopsy , measuring unit Osteon number

  3. Soft tissue reaction [ Time Frame: 4-6 months postoperative ]
    Clinical evaluation by caliber to measure thickness of keratinized mucosa ,measuring unit (mm)

  4. Intraoperative time [ Time Frame: Intraoperative ]
    Using stop watch to measure the operative time


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with deficient alveolar bone in the anterior maxilla.
  • Patient seeking fixed prosthesis at the anterior maxillary region.
  • Highly motivated patients.
  • Good oral hygiene.
  • Patients willing for the surgical procedure and follow-up, with an informed consent.
  • Bounded anterior maxilla cases.

Exclusion Criteria:

  • Medically compromised patients.
  • Uncooperative patients.
  • Poor oral hygiene.
  • Periodontal diseases.
  • No history of any grafting procedure at the designated edentulous ridge.Criteria
  • Patients with any diseases that compromise bone or soft tissue healing.
  • Patients with no local pathosis that interfere with the bone healing.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607006


Contacts
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Contact: Ola A El-Morsy, B.D.S 002-01141234877 dr.ola.elmorsy@gmail.com
Contact: Mohamed M Shaker, PhD 002-01001505798 mouniroma@hotmail.com

Locations
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Egypt
Faculty of Oral and Dental Medicine - Cairo University Recruiting
Giza, Egypt, 12613
Contact: Ola A El-Morsy, B.D.S    002-01141234877    dr.ola.elmorsy@gmail.com   
Contact: Mohamed M Mounir, PhD    002-01001505798    mouniroma@hotmail.com   
Sponsors and Collaborators
Ola Alaa El-Din Abd El-Monem Mohamed
Cairo University
Investigators
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Study Director: Ahmed A Brakart, PhD Cairo University
Study Director: Mohamed M Shaker, PhD Cairo University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ola Alaa El-Din Abd El-Monem Mohamed, Principle Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03607006    
Other Study ID Numbers: CEBD-CU-2018-07-16
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ola Alaa El-Din Abd El-Monem Mohamed, Cairo University:
Anterior maxillary region
Patient specific
Autogenous bone shell
PEEK
Ridge augmentation