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

October 26, 2024 updated by: Motea Abdulsalam Sanad, Cairo University

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)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

22

Phase

  • Phase 3

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

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

No

Description

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 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
Experimental: Group A (Stem cells ,PRF group) intervention group
Biological: 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.
Active Comparator: Group B (PRF group)
Biological: platelet rich fibrin and bone graft
All participants will treated with platelet rich fibrin PRF , bone graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cyst volume
Time Frame: preoperative and 3, 6 months postoperative.
volumetric analysis of cystic defect 3, 6 months after treatment .
preoperative and 3, 6 months postoperative.

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

October 26, 2024

Primary Completion (Estimated)

September 17, 2025

Study Completion (Estimated)

February 22, 2026

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 26, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 26, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMFS 3-3-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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