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NCT Number: NCT07671183

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

* 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

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Key information

Conditions

Mandible Fracture Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Mandibular Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation.

Procedure

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 .

Open Reduction and Internal Fixation

Procedure

Open reduction and internal fixation of fracture line with titanium plates and screws

Primary outcomes

  1. Bone density

    Time frame: 3 months

    Assessment of bone density at fracture healing site by CBCT

Secondary outcomes

  1. Soft tissue dehiscence

    Time frame: 3 month

    Detection of soft tissue dehiscence occurrence (Binary: Yes/ No)

  2. Bleeding

    Time frame: 3 months

    Detection of bleeding occurrence (Binary: Yes/ No)

  3. Infection

    Time frame: 3 months

    Detection of Infection occurrence (Binary: Yes/ No)

  4. Malocclusion

    Time frame: 3 months

    Detection of malocclusion occurrence (Binary: Yes/ No)

Study contacts

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

Mona Mahmoud Abdulhameed

CONTACT

[email protected]

00201001249384

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jun 29, 2026

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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