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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Mandible Fracture

Treatments: Procedure: Open reduction and internal fixation; Procedure: Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation.

Study type: Interventional

Funder types: Other

Identifiers

NCT07671183

3319

Details and patient eligibility

About

• 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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Study group

Experimental group

Description:

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.

Treatment:

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

Control group

Active Comparator group

Description:

10 patients with mandibular fracture will be treated by open reduction and internal fixation with titanium plates and screws.

Treatment:

Procedure: Open reduction and internal fixation