Evaluation of Effect of Bone Marrow Aspirate Concentrate on Distracted Mandibular Bone Properties (NCT03861650) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Effect of Bone Marrow Aspirate Concentrate on Distracted Mandibular Bone Properties
12 participantsStarted 2015-12-30
Plain-language 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
Who can participate
Age range
6 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of effect of BMAC on rapidly distracted bone quality
Timeframe: 6 months
Trial details
NCT IDNCT03861650
SponsorYasser Mohamed Nabil Ahmed Khirat El Hadidi