Evaluation of Effect of Bone Marrow Aspirate Concentrate on Distracted Mandibular Bone Properties
The Effect of Bone Marrow Aspirate Concentrate on Bone Regenerate During Rapid Mandibular Distraction Osteogensis
1 other identifier
interventional
12
0 countries
N/A
Brief Summary
Maxillofacial Distraction Osteogenesis (DO) has a lot of draw backs; mostly related to long distraction and consolidation time. Rapid rate DO was proposed to decrease the distraction time to avoid consequences of long procedure. The idea of the current study is to provide mesenchymal stem cells (MSCs) in form of Bone Marrow Aspirate Concentrate (BMAC) during rapid distraction to fasten and shorten consolidation. Methods: This trial was conducted on patients requiring mandibular DO. Patients were divided in two groups; control group in which distraction took place at a rate of 1.5 mm /day without any enhancement and study group in which distraction took place at rate of 1.5 mm /day and the distracted bone was enhanced by BMAC
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2015
Typical duration for not_applicable
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 Start
First participant enrolled
December 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedFirst Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedMarch 4, 2019
March 1, 2019
3 years
February 27, 2019
March 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of effect of BMAC on rapidly distracted bone quality
radiographically the bone density was assessed using CBCT of the patients to evaluate the effect of BMAC on bone maturation in term of increased bone density measured in Hounsfield unit as the increase in bone density indicates better healing and more bone maturation and justify addition of BMAC
6 months
Study Arms (2)
Bone Marrow Aspirate Concentrate
EXPERIMENTALBone Marrow Aspirate Concentrate is prepared from bone marrow by aspiration by wide bore needle and then prepared by centrifugation to get rich mix of MSCs to improve healing
Saline
SHAM COMPARATORSham or placebo drug in the control group
Interventions
A rich MSCs prepration made by centrifugation and concentration of aspirated bone marrow
Eligibility Criteria
You may qualify if:
- Patients free from any disease affecting bone formation of both sexes was included in the study.
- Patients younger than 25 years old.
- Patients included in the study were post traumatic patients, hemifacial microsomia, Treacher Collins and post ankylotic mandibular deformity.
- Distraction range was between 15-20 mm.
You may not qualify if:
- The presence of uncontrolled systemic disease.
- Previous radiotherapy on head and neck region.
- Chemotherapy within the past 12-month period.
- An active infection at the distraction site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Single blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
February 27, 2019
First Posted
March 4, 2019
Study Start
December 30, 2015
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
March 4, 2019
Record last verified: 2019-03