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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCairo University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with mandibular fracture.

Patients who are willing to participate in the study

Disqualifiers

Patients with systemic diseases influence bone healing

Patients with pathological fractures.

Infection located at the zone to be treated

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bone density

Assessment of bone density at fracture healing site by CBCT

Time frame
3 months

Secondary outcomes

1

Soft tissue dehiscence

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

Time frame
3 month
2

Bleeding

Detection of bleeding occurrence (Binary: Yes/ No)

Time frame
3 months
3

Infection

Detection of Infection occurrence (Binary: Yes/ No)

Time frame
3 months
4

Malocclusion

Detection of malocclusion occurrence (Binary: Yes/ No)

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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