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

Phase 3

Not yet recruiting

• Conditions: Maxillary Cyst
• Interventions: Biological: Bone marrow stem cells concentrate , platelet rich fibrin , bone graft; Biological: platelet rich fibrin and bone graft

• Registration Number: NCT06662604
• Lead Sponsor: Cairo University

Brief Summary

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

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 ).

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study Start: 2024-10-26
• Study First Submitted QC: 2024-10-26
• Last Update Submitted: 2024-10-26
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-09-17
• Study Completion: 2026-02-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Stem cells ,PRF group) intervention group	Bone marrow stem cells concentrate , platelet rich fibrin , bone graft	-
Group B (PRF group)	platelet rich fibrin and bone graft	-

Primary Outcome Measures

Name	Time	Method
cyst volume	preoperative and 3, 6 months postoperative.	volumetric analysis of cystic defect 3, 6 months after treatment .