Effect of Collagen Versus PRF on BMA Osteogenic Potential

Not Applicable

Recruiting

• Conditions: Bone Loss, Alveolar
• Interventions: Procedure: PRF membrane over BMAC/bovine graft in sinus lift; Procedure: Collagen membrane over BMAC/bovine graft in sinus lift

• Registration Number: NCT05985317
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2023-01-25
• Study First Submitted: 2023-07-23
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-08
• Last Update Submitted: 2023-08-08
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF membrane covering BMAC loaded on bovine graft	PRF membrane over BMAC/bovine graft in sinus lift	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
Collagen membrane covering BMAC loaded on bovine graft	Collagen membrane over BMAC/bovine graft in sinus lift	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

Primary Outcome Measures

Name	Time	Method
Radiographic Bone density assessment	4 months ( immediate - 4 months postoperative)	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

Name	Time	Method
Radiographic Bone height assessment	4 months ( immediate - 4 months postoperative)	Assessment of bone hight on CBCT, mmediate and at 4 months postoperative

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt