Mandible FractureNCT07671183
Effect of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate on Bone Quality in Mandibular Fracture Healing.
A study testing Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation. and Open reduction and internal fixation in people with Mandible Fracture, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mandible Fracture
- What is being tested?
- Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation. and Open reduction and internal fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with mandibular fracture.
- Patients who are willing to participate in the study
Who cannot join
- Patients with systemic diseases influence bone healing
- Patients with pathological fractures.
- Infection located at the zone to be treated
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
- 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
- Mandible Fracture
- Being tested
- Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation., Open reduction and internal fixation
- Keywords
- bone quality, bone healing, mandibular fractures, mesenchymal stem cells, randomized clinical trial, fracture repair, bone regeneration, regenerative medicine
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation.Procedure or 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 fixationProcedure or surgery
Open reduction and internal fixation of fracture line with titanium plates and screws
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Procedure: Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation. |
| Control group | Active comparator | 10 patients with mandibular fracture will be treated by open reduction and internal fixation with titanium plates and screws. Receives: Procedure: Open reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Assessment of bone density at fracture healing site by CBCT
Measured: 3 months
Secondary outcomes (4)
Soft tissue dehiscence
Detection of soft tissue dehiscence occurrence (Binary: Yes/ No)
Measured: 3 month
Bleeding
Detection of bleeding occurrence (Binary: Yes/ No)
Measured: 3 months
Infection
Detection of Infection occurrence (Binary: Yes/ No)
Measured: 3 months
Malocclusion
Detection of malocclusion occurrence (Binary: Yes/ No)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandible FractureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mahmoud Abdulhameed, Cairo University
- Investigators
- Mostafa Mohamed El-Gangehi, Professor, Study chair, Faulty of Dentistry, Cairo UniversityWalaa Kadry, Associate Professor, Study director, Faulty of Dentistry, Cairo UniversitySameh Mekhemer, Professor, Study chair, Faulty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671183
- Sponsor's protocol ID
- 3319
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07671183
- Acronym / sponsor ID
- 3319
- Conditions
- Mandible Fracture
- Keywords
- bone quality, bone healing, mandibular fractures, mesenchymal stem cells, randomized clinical trial, fracture repair, bone regeneration, regenerative medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation.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. |
| Control group | Active comparator | Procedure: Open reduction and internal fixation10 patients with mandibular fracture will be treated by open reduction and internal fixation with titanium plates and screws. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with mandibular fracture.
- Patients who are willing to participate in the study
Key exclusion criteria (3 listed)
- Patients with systemic diseases influence bone healing
- Patients with pathological fractures.
- Infection located at the zone to be treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose 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 . | Procedure or surgery | Study group |
| Open reduction and internal fixationOpen reduction and internal fixation of fracture line with titanium plates and screws | Procedure or surgery | Control group |
Primary outcome
Bone density
Time frame: 3 months
Assessment of bone density at fracture healing site by CBCT
4 secondary outcomes
Soft tissue dehiscence
Time frame: 3 month
Bleeding
Time frame: 3 months
Infection
Time frame: 3 months
Malocclusion
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 27513920Castillo-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.
- Individual participant dataSharing planned: Yes
Related trials for Mandible Fracture
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Active, not recruiting
3D Printed Models for Mandibular Fracture Repair
Mandible Fracture, Maxillofacial Trauma
RecruitingPhase 2
Comparison of Submucosal Dexamethasone and Methylprednisolone in Postoperative Sequelae of Parasymphsis Fractures
Mandible Fracture, Edema Face
RecruitingPhase 3
The MANTRA Trial (MANdibular TRauma and Antibiotic Use)
Mandible Fracture, Post-operative Antibiotics
Active, not recruiting
Endoscopically Assisted Management of Maxillofacial Fractures: A Prospective Study on Efficacy and Outcomes
Maxillofacial Injuries, Maxillofacial Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
Questions about this trial
What is this clinical trial studying?
A study testing Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation. and Open reduction and internal fixation in people with Mandible Fracture, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Mahmoud Abdulhameed (00201001249384, monamabdulhameed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07671183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.