Effect of Collagen Versus PRF on BMA Osteogenic Potential
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.
1 other identifier
interventional
2
1 country
1
Brief Summary
Utilization of collagen vs PRF membrane over the graft following sinus lift procedure and before suturing
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2023
CompletedFirst Submitted
Initial submission to the registry
July 23, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedAugust 14, 2023
August 1, 2023
7 months
July 23, 2023
August 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Radiographic Bone height assessment
4 months ( immediate - 4 months postoperative)
Study Arms (2)
Collagen membrane covering BMAC loaded on bovine graft
ACTIVE COMPARATORCollagen 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
PRF membrane covering BMAC loaded on bovine graft
ACTIVE COMPARATORPlatelet 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
Interventions
Collagen membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure
PRF membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry, Cairo University
Cairo, 02, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eman Said
Lecturer at Faculty of Dentistry, Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of oral and Maxillofacial Surgery
Study Record Dates
First Submitted
July 23, 2023
First Posted
August 14, 2023
Study Start
January 25, 2023
Primary Completion
August 30, 2023
Study Completion
August 30, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08