Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine the efficacy of simultaneous innervation to prevent graft bone resorption in maxillofacial reconstruction. It may provide basis for future clinical trials and new strategies for improving the functional reconstruction of large jaw bone defects.

Clinical Trial Description

The use of autograft is still the main method for reconstructing large defects of jaw bones. However, the spontaneous resorption of the graft bone is still severe, and hinders the success of dental implant(s) and chewing function even after microsurgical vascularization. But till now, there is no effective prevention method for this major problem. Based on previous studies, the investigators pioneered a simultaneous innervated vascularized iliac bone graft method, through neurorrhaphy between the nerves innervating iliac bone and recipient site. A clinical retrospective study showed that this new method significantly decreases postoperative osteoporosis, and ensures the success of dental implants (Refer to our published article Wang L*, Wei J, Yang X, Yang Z, Sun M, Cheng X, Xu L, Lei D, Zhang C*. Preventing early-stage graft bone resorption by simultaneous innervation: innervated iliac bone flap for mandibular reconstruction. PlastIc Reconstructive Surgery, 2017, 139(5):1152e-1161e, Cover Featured Article).

The investigators intend to randomly divide the vascularized iliac bone graft cases into traditional group without innervation and simultaneous innervation group (through neurorrhaphy between the nerves innervating iliac bone flap and recipient site). The efficacy of simultaneously innervated maxillofacial reconstruction for preventing graft bone resorption will be assessed using bone mineral density test of grafted bone, as a blinded method. The innervation and sensation of the internal oblique abdominis muscle island will be tested using neuroelectrophysiological examination. The recipient nerve having the best effect on preventing bone resorption, will be determined using hierarchical comparison method. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03889587
Study type	Interventional
Source	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact	Wang Lei, MD,PhD
Phone	+86 15921941601
Email	wangleizyh@aliyun.com
Status	Recruiting
Phase	N/A
Start date	May 8, 2019
Completion date	December 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction — INVITATION

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms