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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
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Mandibular Fractures by Cairo University — 6 open to participants now, 7 under way, none of them phase 3. Mandibular Fractures · Cairo University.

Planned enrollment
9th of 18
20 · median 20
Started
2026
with 4 others
No phase
18 of 20
6 open now
Registered
17th of 20
by date

Among the 20 studies in Mandibular Fractures by Cairo University, this one is the 9th largest by planned enrollment of the 18 interventional ones, is one of 5 that started in 2026, is one of 18 with no phase, and was the 17th registered.

By phase

20 studies; the count open now beside each. This study's row is marked.

No phasethis study18 · 6 open
Observational2 · 0 open

By the year they started

First in 2017; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 20 across the 18 interventional studies, 183 across the 2 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 20 studies in Mandibular Fractures by Cairo University, or all of them as a file.
02

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.
03

Conditions studied

  • Mandible Fracture

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Keywords

  • bone quality
  • bone healing
  • mandibular fractures
  • mesenchymal stem cells
  • randomized clinical trial
  • fracture repair
  • bone regeneration
  • regenerative medicine
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

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, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Feb 2027, 7 months later.

Of 38 non-industry interventional studies with no phase under Mandibular Fractures, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 7 months is below that.

Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 9 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2026
First posted
Jun 26, 2026
StartEst.
Jul 2026
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
Jun 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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