Effect of Collagen Versus PRF on BMA Osteogenic Potential

Bone Loss, Alveolar Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985317
• Other study ID #: The membrane effect on the BM
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Walaa Kadry
• Phone: +201061527359
• Email: walaakadry[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar

Intervention

Procedure:
• Collagen membrane over BMAC/bovine graft in sinus lift
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 over BMAC/bovine graft in sinus lift
PRF membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Radiographic Bone height assessment	Assessment of bone hight on CBCT, mmediate and at 4 months postoperative	4 months ( immediate - 4 months postoperative)