Effect of Collagen Versus PRF on BMA Osteogenic Potential

August 8, 2023 updated by: Walaa Kadry, Cairo University

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Recruiting
        • Faculty of Dentistry, Cairo University
        • Contact:
          • Walaa Kadry, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Collagen membrane covering BMAC loaded on bovine graft
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
Collagen membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure
Active Comparator: PRF membrane covering BMAC loaded on bovine graft
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
PRF membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Bone density assessment
Time Frame: 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
4 months ( immediate - 4 months postoperative)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Eman Said, Lecturer at Faculty of Dentistry, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

August 30, 2023

Study Completion (Estimated)

August 30, 2023

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The membrane effect on the BM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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