Mandibular FracturesPhase 3NCT02755922
Bone Regeneration With Mesenchymal Stem Cells
A Phase 3 study testing Application of autologous mesenchymal stem cells in people with Mandibular Fractures, run by Instituto Mexicano del Seguro Social.
Trial summary
Mandible fractures are a common cause of facial injury in adults. The autologous mesenchymal stem cell (AMSC) transplantation, is proposed as an alternative to the conventional graft treatment, improving bone neoformation.The objective was to evaluate the effectiveness of AMSCs application in mandibular fractures to… Read more about this study
- Who is it for?
- Ages 17 to 59 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Application of autologous mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 17 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Entitled patients to the Mexican Institute of Social Security
- Patients with mandibular condyle fractures associated or not to other initial fracture that required Open reduction and internal fixation
- Ages from 17 to 59 years
- Both female and male gender
- Patients who gave their consent to be part of this trial
Who cannot join
- Patients younger than 17 years and older than 59 years
- Chronic-degenerative diseases, active smoking, collagen disorders
- Patients with signs of infection in the aimed area to treat and in whom the fracture occurred in a longer period than 10 days before their surgery.
About this study
Official title: Bone Regeneration in Mandibular Fractures After the Application of Autologous Mesenchymal Stem Cells. Randomized Clinical Trial.
Mandible fractures are a common cause of facial injury in adults. The autologous mesenchymal stem cell (AMSC) transplantation, is proposed as an alternative to the conventional graft treatment, improving bone neoformation.The objective was to evaluate the effectiveness of AMSCs application in mandibular fractures to reduce regeneration time and increase bone quality.
Read the detailed description
Single blinded controlled clinical trial in patients with mandibular angle fracture. The patients were divided into: Study Group (SG): fracture reduction plus application of AMSCs, Control Group (CG): Same procedure without AMSCs. AMSCs were obtained from adipose tissue , 24 hrs before the procedure. Intensity and density were evaluated in normal bone and fractured bone, at 4 and 12 weeks after surgery using panoramic radiography and computed tomography. (CT)
A total of 20 patients, 10 in each group were included. SG with a mean age of 31.2 ± 6.3 years and CG 29.7 ± 7.2 years, all patients were male. Bone quality at week 4 SG 108.82 ± 3.4 vs CG 93.92 ± 2.6 (p = 0.000) by panoramic radiography, SG 123 ± 4.53 vs CG 99.72 ± 5.72 (p = 0.000) by CT. At week 12: SG 153.53±1.83 vs CG 101.81±4.83 (p= 0.000) by panoramic radiography, SG 165.4 ± 4.2 vs CG 112.05±2.1 (p= 0.000) by CT.
The application of AMSCs presented at week 4 similar ossification values compared with normal bone and a 36.48 % higher ossification rate at week 12.
- Conditions
- Mandibular Fractures
- Being tested
- Application of autologous mesenchymal stem cells
- Keywords
- Mesenchymal Stem Cells, Treatment
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of autologous mesenchymal stem cellsBiological
within the surgical procedure, mesenchymal stem cells, were applied on the fracture site. Imaging by X-ray and CT and imaging analysis was done after fracture repair, at week 4 and week 12
| Study group | Role | What they receive |
|---|---|---|
| Fractures with Mesenchymal Stem Cells | Experimental | 10 patients with mandibular fractures were managed by open reduction and internal fixation, with application of autologous mesenchymal stem cells on the fracture site. Receives: Biological: Application of autologous mesenchymal stem cells |
| Fractures without Mesenchymal Stem Cells | No intervention | 10 patients with mandibular fractures were managed by open reduction and internal fixation, without application of autologous mesenchymal stem cells on the fracture site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bone quality
After the procedure, imaging control by X-ray and analysis by software, was done after surgery at weeks 4 and 12. X- ray units: Voxels. Software analysis by Image Processing and Analysis ImageJ 1.43
Measured: from the moment of fracture diagnosis to week 4 and week 12 after surgery
Change of bone quality
After the procedure, imaging control by CT scan and analysis by software, was done after surgery at weeks 4 and 12. CT scan units: Hounsfiled . Software analysis by Image Processing and Analysis ImageJ 1.43
Measured: from the moment of fracture diagnosis to week 4 and week 12 after surgery
Secondary outcomes (3)
Number of patients with infection ( increase of local temperature, tenderness, leukocyte count >10,000/ µL, confirmed by Gram stain and blood culture).
Infection suggested by clinical diagnosis increase of leukocyte levels, and confirmed by Gram stain and blood culture of local sample.
Measured: from immediate postoperative period to three months after surgery
Number of patients with bleeding after surgery (Persistent bleeding, ineffectiveness stopping bleeding using dressings)
Persistent bleeding after surgery, that did not stop by dressings. If this complication developed, it had to be managed by surgical techniques.
Measured: from immediate postoperative period to 1 week after surgery
Number of patients with surgical wound dehiscence (subcutaneous tissue , bone or osteosynthesis material exposed and seen through opened skin )
Clinical signs of dehiscence on the surgical incision, surgical material or bone seen though the skin. This diagnosis is done by clinical findings. Does not need any laboratory or image test.
Measured: from immediate postoperative period to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social
- Investigators
- Alejandro Gonzalez Ojeda, M.D., Ph.D., Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755922
- Sponsor's protocol ID
- 2010-1301-27
- Status last verified
- Apr 2016
- First submitted
- 20 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Regeneration in Mandibular Fractures After the Application of Autologous Mesenchymal Stem Cells. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02755922
- Acronym / sponsor ID
- 2010-1301-27
- Conditions
- Mandibular Fractures
- Keywords
- Mesenchymal Stem Cells, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Apr 2016 (estimated)
- 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.
Mandible fractures are a common cause of facial injury in adults. The autologous mesenchymal stem cell (AMSC) transplantation, is proposed as an alternative to the conventional graft treatment, improving bone neoformation.The objective was to evaluate the effectiveness of AMSCs application in mandibular fractures to reduce regeneration time and increase bone quality.
Detailed description
Single blinded controlled clinical trial in patients with mandibular angle fracture. The patients were divided into: Study Group (SG): fracture reduction plus application of AMSCs, Control Group (CG): Same procedure without AMSCs. AMSCs were obtained from adipose tissue , 24 hrs before the procedure. Intensity and density were evaluated in normal bone and fractured bone, at 4 and 12 weeks after surgery using panoramic radiography and computed tomography. (CT)
A total of 20 patients, 10 in each group were included. SG with a mean age of 31.2 ± 6.3 years and CG 29.7 ± 7.2 years, all patients were male. Bone quality at week 4 SG 108.82 ± 3.4 vs CG 93.92 ± 2.6 (p = 0.000) by panoramic radiography, SG 123 ± 4.53 vs CG 99.72 ± 5.72 (p = 0.000) by CT. At week 12: SG 153.53±1.83 vs CG 101.81±4.83 (p= 0.000) by panoramic radiography, SG 165.4 ± 4.2 vs CG 112.05±2.1 (p= 0.000) by CT.
The application of AMSCs presented at week 4 similar ossification values compared with normal bone and a 36.48 % higher ossification rate at week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractures with Mesenchymal Stem Cells | Experimental | Biological: Application of autologous mesenchymal stem cells10 patients with mandibular fractures were managed by open reduction and internal fixation, with application of autologous mesenchymal stem cells on the fracture site. |
| Fractures without Mesenchymal Stem Cells | No intervention | –10 patients with mandibular fractures were managed by open reduction and internal fixation, without application of autologous mesenchymal stem cells on the fracture site. |
Who may qualify
- Ages
- 17 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Entitled patients to the Mexican Institute of Social Security
- Patients with mandibular condyle fractures associated or not to other initial fracture that required Open reduction and internal fixation
- Ages from 17 to 59 years
- Both female and male gender
- Patients who gave their consent to be part of this trial
Key exclusion criteria (3 listed)
- Patients younger than 17 years and older than 59 years
- Chronic-degenerative diseases, active smoking, collagen disorders
- Patients with signs of infection in the aimed area to treat and in whom the fracture occurred in a longer period than 10 days before their surgery.
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 |
|---|---|---|
| Application of autologous mesenchymal stem cellswithin the surgical procedure, mesenchymal stem cells, were applied on the fracture site. Imaging by X-ray and CT and imaging analysis was done after fracture repair, at week 4 and week 12 | Biological | Fractures with Mesenchymal Stem Cells |
Primary outcome
Change of bone quality
Time frame: from the moment of fracture diagnosis to week 4 and week 12 after surgery
After the procedure, imaging control by X-ray and analysis by software, was done after surgery at weeks 4 and 12. X- ray units: Voxels. Software analysis by Image Processing and Analysis ImageJ 1.43
Change of bone quality
Time frame: from the moment of fracture diagnosis to week 4 and week 12 after surgery
After the procedure, imaging control by CT scan and analysis by software, was done after surgery at weeks 4 and 12. CT scan units: Hounsfiled . Software analysis by Image Processing and Analysis ImageJ 1.43
3 secondary outcomes
Number of patients with infection ( increase of local temperature, tenderness, leukocyte count >10,000/ µL, confirmed by Gram stain and blood culture).
Time frame: from immediate postoperative period to three months after surgery
Number of patients with bleeding after surgery (Persistent bleeding, ineffectiveness stopping bleeding using dressings)
Time frame: from immediate postoperative period to 1 week after surgery
Number of patients with surgical wound dehiscence (subcutaneous tissue , bone or osteosynthesis material exposed and seen through opened skin )
Time frame: from immediate postoperative period to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Individual participant dataSharing planned: Yes
Related trials for Mandibular Fractures
Recruiting
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
Pediatric Mandibular Fracture
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
Recruiting
Bony Overlap Following Use of the Inferior Border Saw for the 'Low and Short' Sagittal Split: A Split-Mouth Study
Mandibular Surgery
Not yet recruiting
Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures
Mandibular Fractures, Maxillofacial Injuries
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. This study is not recruiting at the moment.
Alejandro Gonzalez Ojeda, M.D., Ph.D. principal investigator
Instituto Mexicano del Seguro Social
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Application of autologous mesenchymal stem cells in people with Mandibular Fractures, run by Instituto Mexicano del Seguro Social.
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 5 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: finished, as of the sponsor's last update on 29 Apr 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of bone quality (time frame: from the moment of fracture diagnosis to week 4 and week 12 after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2016.