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NCT Number: NCT06662604

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

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

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Key information

Conditions

Maxillary Cyst Bone Cysts Cysts Jaw Cysts Jaw Diseases Musculoskeletal Diseases Neoplasms Stomatognathic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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 ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

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

platelet rich fibrin and bone graft

Biological

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

Primary outcomes

  1. cyst volume

    Time frame: preoperative and 3, 6 months postoperative.

    volumetric analysis of cystic defect 3, 6 months after treatment .

Study contacts

Contact information is provided by the study sponsor or research team.

Motea Abdulsalm Sanad, PHD

CONTACT

[email protected]

+20 1090696248

Tareq El-Ghareeb, Professor

CONTACT

[email protected]

+201282931864

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Bone Marrow Stem Cells Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Regeneration of Maxillary Cystic Defects Versus Platelet Rich Fibrin with Bone Graft (a Randomized Controlled Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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