Back to resultsEffect of Collagen Versus PRF on BMA Osteogenic Potential
Primary Purpose
Bone Loss, Alveolar
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Collagen membrane over BMAC/bovine graft in sinus lift
PRF membrane over BMAC/bovine graft in sinus lift
Sponsored by
About this trial
This is an interventional treatment trial for Bone Loss, Alveolar
Eligibility Criteria
Inclusion Criteria: Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement. Highly motivated patients Age more than 18 years Exclusion Criteria: Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing. Patients suffering from any sinus pathosis. Patients with conditions that could potentially compromise Bone Marrow ( BM)quality, including history of hematologic malignancy, current chemotherapy, BM suppressive and anti-platelet medications, previous BM Aspiration, or acute illness. Heavy smoker (> 20 cigarettes daily)
Sites / Locations
- Faculty of Dentistry, Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Collagen membrane covering BMAC loaded on bovine graft
PRF membrane covering BMAC loaded on bovine graft
Arm Description
Collagen membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative
Platelet rich fibrin membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative
Outcomes
Primary Outcome Measures
Radiographic Bone density assessment
Bone density measurements on Cone beam CT/CBCT immediate and 4 months radiographic density measurements in haunsfield units, immediate and 4 months postoperative
Secondary Outcome Measures
Radiographic Bone height assessment
Assessment of bone hight on CBCT, mmediate and at 4 months postoperative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05985317
Brief Title
Effect of Collagen Versus PRF on BMA Osteogenic Potential
Official Title
Evaluation of Collagen Versus Platelet Rich Fibrin Membrane on the Osteogenic Potential of Bone Marrow Aspirate Concentrate (BMAC) for Lateral Sinus Floor Augmentation : A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (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
Utilization of collagen vs PRF membrane over the graft following sinus lift procedure and before suturing
Detailed Description
Assessment of the effect of membrane overlying bone marrow aspirate concentrate - bovine graft mixture in sinus lift procedure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Alveolar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collagen membrane covering BMAC loaded on bovine graft
Arm Type
Active Comparator
Arm Description
Collagen membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative
Arm Title
PRF membrane covering BMAC loaded on bovine graft
Arm Type
Active Comparator
Arm Description
Platelet rich fibrin membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative
Intervention Type
Procedure
Intervention Name(s)
Collagen membrane over BMAC/bovine graft in sinus lift
Intervention Description
Collagen membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure
Intervention Type
Procedure
Intervention Name(s)
PRF membrane over BMAC/bovine graft in sinus lift
Intervention Description
PRF membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure
Primary Outcome Measure Information:
Title
Radiographic Bone density assessment
Description
Bone density measurements on Cone beam CT/CBCT immediate and 4 months radiographic density measurements in haunsfield units, immediate and 4 months postoperative
Time Frame
4 months ( immediate - 4 months postoperative)
Secondary Outcome Measure Information:
Title
Radiographic Bone height assessment
Description
Assessment of bone hight on CBCT, mmediate and at 4 months postoperative
Time Frame
4 months ( immediate - 4 months postoperative)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement.
Highly motivated patients
Age more than 18 years
Exclusion Criteria:
Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing.
Patients suffering from any sinus pathosis.
Patients with conditions that could potentially compromise Bone Marrow ( BM)quality, including history of hematologic malignancy, current chemotherapy, BM suppressive and anti-platelet medications, previous BM Aspiration, or acute illness.
Heavy smoker (> 20 cigarettes daily)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walaa Kadry
Phone
+201061527359
Email
walaakadry@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Abmed Amin
Phone
+201061527358
Email
ahmamin2001.aa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Said
Organizational Affiliation
Lecturer at Faculty of Dentistry, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walaa Kadry, Phd
12. IPD Sharing Statement
Learn more about this trial
Effect of Collagen Versus PRF on BMA Osteogenic Potential
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