Effect of Collagen Versus PRF on BMA Osteogenic Potential

Study Overview
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Brief Summary
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Utilization of collagen vs PRF membrane over the graft following sinus lift procedure and before suturing

Detailed Description
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Assessment of the effect of membrane overlying bone marrow aspirate concentrate - bovine graft mixture in sinus lift procedure

Official Title
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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.

Conditions
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Bone Loss, Alveolar

Intervention / Treatment
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* Procedure: Collagen membrane over BMAC/bovine graft in sinus lift
* Procedure: PRF membrane over BMAC/bovine graft in sinus lift


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Collagen membrane covering BMAC loaded on bovine graft<br>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 | Procedure: Collagen membrane over BMAC/bovine graft in sinus lift<br>* Collagen membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure<br>|
| Active Comparator: PRF membrane covering BMAC loaded on bovine graft<br>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 | Procedure: PRF membrane over BMAC/bovine graft in sinus lift<br>* PRF membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 months ( immediate - 4 months postoperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Bone height assessment | Assessment of bone hight on CBCT, mmediate and at 4 months postoperative | 4 months ( immediate - 4 months postoperative) |