Effect of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate on Bone Quality in Mandibular Fracture Healing.

June 25, 2026 updated by: Mona Mahmoud Abdulhameed, Cairo University

Bone Quality Assessment Following Application of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate in the Management of Mandibular Fractures. A Randomized Clinical Trial

  • The goal of study is to evaluate the effectiveness of adipose tissue derived-MSCs concentrate application in mandibular fractures. The main question it aims to answer is: Does intervention enhance bone quality, reduce complications and reduce bone regeneration time.
  • Researchers will compare the effectiveness of adipose tissue derived-MSCs concentrate application with ORIF to ORIF alone to see if MSCs improve healing in mandibular fractures.

  • Participants will:

    • Be managed either by adipose tissue derived-MSCs concentrate application with ORIF or ORIF alone.
    • Undergo CBCT immediately (T1) and 3 months (T4) postoperatively for bone density radiographic evaluation
    • Visit the clinic postoperatively at one week (T2), one month (T3), three months (T4) for clinical examination

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • From oral and maxillofacial surgery outpatient clinic, Faculty of Dentistry, Cairo University. 20 patients will be included in this study, the patients will be randomly distributed into two groups each containing 10 patients, one group will be treated by application of adipose tissue derived autologous mesenchymal stem cell concentrate before and after fixation and the other group will be treated by fixation only without application of adipose tissue derived autologous mesenchymal stem cell concentrate.
  • All surgeries (for study and control groups) will be carried out with endotracheal intubation under general anaesthesia.
  • After scrubbing the surgical field with a povidone-iodine surgical scrub solution, the patients will be draped in sterile towels such that only the surgical site will be visible.
  • The fracture line will be exposed, followed by mobilization of the fracture, and removal of any soft tissue entrapped within the fracture line. Intermaxillary fixation (IMF) will be done and temporarily secured to provide proper occlusion that will serve as a guide for fracture reduction.
  • The reduction of the bone into appropriate anatomical occlusion will then be visually verified by confirming that the mandible is properly aligned. After that, the titanium plate is positioned and secured with titanium screws.
  • For the study group, abdominal lipo- suction will be carried out for the subsequent receive and gain of fat-derived stem cells following the microfragmentation of adipose tissue. This lipo-aspirate containing MSCs will be applied on fracture line before and following fixation.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

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

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:

  • Patients with mandibular fracture.
  • Patients who are willing to participate in the study

Exclusion Criteria:

  • Patients with systemic diseases influence bone healing
  • Patients with pathological fractures.
  • Infection located at the zone to be treated

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
10 patients with mandibular fracture will be treated by application of adipose tissue derived MSCs concentrate on fracture line before and following fixation with titanium plates and screws.
Procedure: Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation.
Abdominal fat liposuction will be carried out, microfragmentation of adipose tissue will be performed. Then the filtrate containing mesenchymal stem cells concentrate will be applied to the fracture line before and following fixation with titanium plates and screws .
Active Comparator: Control group
10 patients with mandibular fracture will be treated by open reduction and internal fixation with titanium plates and screws.
Procedure: Open reduction and internal fixation
Open reduction and internal fixation of fracture line with titanium plates and screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density
Time Frame: 3 months
Assessment of bone density at fracture healing site by CBCT
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue dehiscence
Time Frame: 3 month
Detection of soft tissue dehiscence occurrence (Binary: Yes/ No)
3 month
Bleeding
Time Frame: 3 months
Detection of bleeding occurrence (Binary: Yes/ No)
3 months
Infection
Time Frame: 3 months
Detection of Infection occurrence (Binary: Yes/ No)
3 months
Malocclusion
Time Frame: 3 months
Detection of malocclusion occurrence (Binary: Yes/ No)
3 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Mostafa Mohamed El-Gangehi, Professor, Faulty of Dentistry, Cairo University
  • Study Director: Walaa Kadry, Associate Professor, Faulty of Dentistry, Cairo University
  • Study Chair: Sameh Mekhemer, Professor, Faulty of Dentistry, 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

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)

July 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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