Using of Bone Marrow Stem Cell Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Reconstruction of Upper Jaw Bony Cystic Defects, Comparing with Platelet Rich Fibrin with Bone Graft

NCT ID: NCT06662604

Last Updated: 2024-10-29

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

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-26

Study Completion Date

2026-02-22

Brief Summary

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Will the use of bone marrow stem cells with platelet rich fibrin enhance and accelerate the bone regeneration in the upper jaw cystic defects ?

Detailed Description

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Reconstruction of critical size bone defect in maxillofacial surgery is a great challenge, current practice of bone reconstruction still having problems like delay in bone regeneration (up to 12 months) and bone graft failure and low availability of autogenous bone graft.

last decade stem cells therapy gained great interest, in many studies Bone marrow stem cells showed promising result in bone regeneration enhancing .

Platelet Rich Fibrin PRF also capability of enhancing bone and tissue regeneration by releasing of certain protein molecules call growth factors that initiate sequential biological events resulting in stem cells migration into the site of bone defect and differentiation to bone formation cells (osteoblast cells ).

Conditions

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Maxillary Cyst

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A (Stem cells ,PRF group) intervention group

Group Type EXPERIMENTAL

Bone marrow stem cells concentrate , platelet rich fibrin , bone graft

Intervention Type BIOLOGICAL

All participants will be treated with Bone marrow stem cells concentrate , platelet rich fibrin , bone graft.

Group B (PRF group)

Group Type ACTIVE_COMPARATOR

platelet rich fibrin and bone graft

Intervention Type BIOLOGICAL

All participants will treated with platelet rich fibrin PRF , bone graft.

Interventions

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Bone marrow stem cells concentrate , platelet rich fibrin , bone graft

All participants will be treated with Bone marrow stem cells concentrate , platelet rich fibrin , bone graft.

Intervention Type BIOLOGICAL

platelet rich fibrin and bone graft

All participants will treated with platelet rich fibrin PRF , bone graft.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age range 18-50 years
* Patients with a critical size maxillary cyst. (\>3 cm)
* Patients that free of any significant medical conditions that could affect healing or outcomes.

Exclusion Criteria

* Patients with large jaw cyst that endanger vital structures
* Patients with significant medical condition
* age under 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Motea Abdulsalam Sanad

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Motea Abdulsalm Sanad, PHD

Role: CONTACT

+20 1090696248

Tareq El-Ghareeb, Professor

Role: CONTACT

+201282931864

References

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Liu M, Liu Y, Luo F. The role and mechanism of platelet-rich fibrin in alveolar bone regeneration. Biomed Pharmacother. 2023 Dec;168:115795. doi: 10.1016/j.biopha.2023.115795. Epub 2023 Nov 2.

Reference Type BACKGROUND
PMID: 37918253 (View on PubMed)

Matsumura-Matsuo M, To M, Okudera T, Matsuo M. Regeneration processes of alveolar bone and microvascular changes after the application of platelet-rich fibrin. J Oral Biosci. 2023 Sep;65(3):218-225. doi: 10.1016/j.job.2023.05.004. Epub 2023 Jun 3.

Reference Type BACKGROUND
PMID: 37277026 (View on PubMed)

Fitzsimmons REB, Mazurek MS, Soos A, Simmons CA. Mesenchymal Stromal/Stem Cells in Regenerative Medicine and Tissue Engineering. Stem Cells Int. 2018 Aug 19;2018:8031718. doi: 10.1155/2018/8031718. eCollection 2018.

Reference Type BACKGROUND
PMID: 30210552 (View on PubMed)

Manfrini M, Di Bona C, Canella A, Lucarelli E, Pellati A, D'Agostino A, Barbanti-Brodano G, Tognon M. Mesenchymal stem cells from patients to assay bone graft substitutes. J Cell Physiol. 2013 Jun;228(6):1229-37. doi: 10.1002/jcp.24276.

Reference Type BACKGROUND
PMID: 23129455 (View on PubMed)

Related Links

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Other Identifiers

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OMFS 3-3-18

Identifier Type: -

Identifier Source: org_study_id

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