NCT07671183

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 22, 2026

Last Update Submit

June 25, 2026

Conditions

Mandible Fracture

Keywords

bone qualitybone healingmandibular fracturesmesenchymal stem cellsrandomized clinical trialfracture repairbone regenerationregenerative medicine

Outcome Measures

Primary Outcomes (1)

  • Bone density

    Assessment of bone density at fracture healing site by CBCT

    3 months

Secondary Outcomes (4)

  • Soft tissue dehiscence

    3 month

  • Bleeding

    3 months

  • Infection

    3 months

  • Malocclusion

    3 months

Study Arms (2)

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.

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.

Procedure: Open reduction and internal fixation

Interventions

Open reduction and internal fixationPROCEDURE

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

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

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 .

Study group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27513920RESULT

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Fracture Fixation, InternalOpen Fracture Reduction

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Mostafa Mohamed El-Gangehi, Professor

    Faulty of Dentistry, Cairo University

    STUDY CHAIR

  • Walaa Kadry, Associate Professor

    Faulty of Dentistry, Cairo University

    STUDY DIRECTOR

  • Sameh Mekhemer, Professor

    Faulty of Dentistry, Cairo University

    STUDY CHAIR

Central Study Contacts

Mona Mahmoud Abdulhameed

CONTACT

00201001249384monamabdulhameed@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE