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Mandibular magnetic distractor: preclinical validation
N Kadlub1, J Dallard2, N Kogane2
1Unit of maxillofacial and plastic surgery, Reference Center for Cleft and Facial Malformation, Necker Children Hospital, 149 rue de Sèvres, Paris, France; University of Paris, Paris, France.
The British Journal of Oral & Maxillofacial Surgery
|May 11, 2022
Summary
This study shows a new biocompatible device for magnetic mandibular distraction is feasible. Cadaver tests confirmed successful distraction, with surgeons satisfied with the novel internal device for improved patient comfort.
Area of Science:
- Biomaterials Science
- Orthodontics
- Surgical Devices
Background:
- Previous studies demonstrated magnetic activation for mandibular distraction.
- A novel biocompatible device was developed for evaluating distraction feasibility.
Purpose of the Study:
- To assess the feasibility of mandibular distraction using a new device in cadaveric subjects.
- To evaluate the device's functionality through bench testing and cadaveric trials.
Main Methods:
- Measured transmitted torque between internal and external magnets at varying distances.
- Evaluated device friction force and magnet resilience to sterilization.
- Conducted cadaveric tests and surgeon satisfaction assessments.
Main Results:
- A friction torque of 65.10-3 N.mm was determined in the distractor mechanism.
- Sterilization did not affect magnet properties.
- Successful mandibular distraction was achieved in cadaveric trials with high surgeon satisfaction.
Conclusions:
- The developed biocompatible device is feasible for mandibular distraction.
- The device's internal nature may enhance patient comfort.
- Further clinical trials are warranted after regulatory approval.
