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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation.
Procedure/SurgeryAbdominal 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/SurgeryOpen reduction and internal fixation of fracture line with titanium plates and screws
Treatment groups
Trial outcomes
Primary outcomes
Bone density
Assessment of bone density at fracture healing site by CBCT
Secondary outcomes
Soft tissue dehiscence
Detection of soft tissue dehiscence occurrence (Binary: Yes/ No)
Bleeding
Detection of bleeding occurrence (Binary: Yes/ No)
Infection
Detection of Infection occurrence (Binary: Yes/ No)
Malocclusion
Detection of malocclusion occurrence (Binary: Yes/ No)
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: