Effect of Collagen Versus PRF on BMA Osteogenic Potential

NCT ID: NCT05985317

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-25

Study Completion Date

2023-08-30

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

Conditions

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Bone Loss, Alveolar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Collagen membrane over BMAC/bovine graft in sinus lift

Intervention Type PROCEDURE

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 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

Group Type ACTIVE_COMPARATOR

PRF membrane over BMAC/bovine graft in sinus lift

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Walaa Kadry

Lecturer of oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Said

Role: STUDY_DIRECTOR

Lecturer at Faculty of Dentistry, Cairo University

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Walaa Kadry

Role: CONTACT

+201061527359

Abmed Amin

Role: CONTACT

+201061527358

Facility Contacts

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Walaa Kadry, Phd

Role: primary

Other Identifiers

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The membrane effect on the BM

Identifier Type: -

Identifier Source: org_study_id

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