The Effect of Bone Marrow Aspirate Concentrate on Bone Regenerate During Rapid Mandibular Distraction Osteogensis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Primary Endpoint
- Assessment of effect of BMAC on rapidly distracted bone quality
Study Overview
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
Detailed Description
Material and Methods:
A prospective case-control trial was conducted on patients requiring mandibular distraction osteogenesis to assess the effect of BMAC on distracted bone quality. Evaluation of newly formed bone quantity and quality was done using a CBCT which was done post distractor removal as a part of routine follow up ( in agreement with European guidelines for the exposure to ionizing radiation) and evaluation of the bone quality was assessed by two examiners to provide interexaminer-reliability.
In order to evaluate the effect of BMAC on bone maturation and possibility of early removal of the distractor; which was not feasible in the clinical study due to the ethical concerns. Mechanical three point bending was applied on distracted mandible after 30 days following distraction to evaluate bone healing and mechanical strength of distracted bone. In addition to histological and radiographic evaluation.
Patients and methods:
Patient grouping and anesthetic technique:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
Single blinded
Eligibility Criteria
- Ages
- 6 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Saline
Sham or placebo drug in the control group
Intervention: Saline (Other)
Bone Marrow Aspirate Concentrate
Bone 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
Intervention: Bone Marrow Aspirate Concentrate (Other)
Outcomes
Primary Outcomes
Assessment of effect of BMAC on rapidly distracted bone quality
Time Frame: 6 months
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Yasser Mohamed Nabil Ahmed Khirat El Hadidi
Assistant Lecturer
Ain Shams University