Not yet recruitingNCT07671183Updated Jun 29, 2026

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

An interventional study of Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation. and Open reduction and internal fixation in Mandible Fracture, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Mandible Fracture

Browse trials for

Mandibular Fractures 79

Keywords

bone quality
bone healing
mandibular fractures
mesenchymal stem cells
randomized clinical trial
fracture repair
bone regeneration
regenerative medicine

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 20 participants (estimated)

Study arms

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.
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

Interventions

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

What researchers measure

Primary outcomes

Bone density
Assessment of bone density at fracture healing site by CBCT
Time frame: 3 months

Secondary outcomes

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

Study locations

No study locations are listed for this record.

References and documents

Publications

Castillo-Cardiel G, Lopez-Echaury AC, Saucedo-Ortiz JA, Fuentes-Orozco C, Michel-Espinoza LR, Irusteta-Jimenez L, Salazar-Parra M, Gonzalez-Ojeda A. Bone regeneration in mandibular fractures after the application of autologous mesenchymal stem cells, a randomized clinical trial. Dent Traumatol. 2017 Feb;33(1):38-44. doi: 10.1111/edt.12303. Epub 2016 Sep 13. PubMed 27513920 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

Registry details

Key details

Study ID: NCT07671183
Lead sponsor: Cairo University
Responsible party: Mona Mahmoud Abdulhameed (Principal Investigator, Cairo University) — Principal investigator
First posted: Jun 26, 2026
Start date: Jul 2026 (estimated)
Primary completion: Feb 2027 (estimated)
Completion: Feb 2027 (estimated)
Last update: Jun 29, 2026

Study contacts

Mona Mahmoud Abdulhameed

Contact

monamabdulhameed@gmail.com

00201001249384

Mostafa Mohamed El-Gangehi, Professor

study chair · Faulty of Dentistry, Cairo University

Walaa Kadry, Associate Professor

study director · Faulty of Dentistry, Cairo University

Sameh Mekhemer, Professor

study chair · Faulty of Dentistry, Cairo University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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