Every year, about thirty thousand cases of oral cancer are diagnosed in the United States; for which the basic treatment is surgical excision of hard and soft tissues of the face. Tumor excision may be combined with radiotherapy, which compromises the vascularity of the remaining tissues. Benign tumors of the mandible may also require segmental bone resection due to high incidence of local recurrence after simple curettage or intra-lesion excision. Furthermore, segmental bone loss may result from blast injuries, high impact trauma, or repeated surgical debridement for treatment of chronic osteomyelitis of the mandible. Surgical excision of hard and soft tissues of the head and neck or high impact trauma can lead to major tissue deficits. Reconstruction of the lower jaw typically involves bone, gingiva, and teeth. Current mandibular distraction devices are used in combination with reconstruction plates, but while the reconstruction plates take the contour of the jaw, the distraction devices have a linear vector. The devices also have a limited distraction distance, producing short segments of straight bone and so cannot accommodate large deficits with a single procedure. A robust prototype intra-oral mandibular distraction device (BTRP-01) was built using Phase I STTR funding, and was shown to be mechanically robust, easy to place and use, and able to successfully transport a dentate bone segment across a 2 cm bony gap in a live goat model. The objective of Phase I of this STTR proposal is to create a Finite Element Model (FEM) of human mandibles and of the device, and establish the least robust form of the device to be used in humans that is able to withstand a range of external mechanical forces. We will install and test a Mini Mill Vertical Machining Center for precision manufacturing of the less robust forms of device, and mechanically test these devices to confirm the predictions of the FEM. The purpose of this proposal is to create a less robust form of the device suitable for use in humans in Phase II. Critical features of this proposal are the use of finite element modeling to determine optimal dimensions of the device, and precision manufacturing of smaller, more compact devices for improved treatment and enhanced patient comfort. Every year, about thirty thousand cases of oral cancer are diagnosed in the United States; for which the basic treatment is surgical excision of hard and soft tissues of the face, leading to major tissue deficits. Current mandibular distraction devices are used in combination with reconstruction plates, but while the reconstruction plates take the contour of the jaw, the distraction devices have a linear vector. A robust prototype intra-oral mandibular distraction device was shown to be mechanically robust, easy to place and use, and able to successfully transport a dentate bone segment across a 2 cm bony gap in a live goat model. The objective of Phase I of this STTR proposal is to determine optimal dimensions for precision manufacturing of smaller, more compact devices for improved treatment and enhanced patient comfort. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DE017259-01A1
Application #
7217470
Study Section
Special Emphasis Panel (ZRG1-MOSS-K (11))
Program Officer
Drummond, James
Project Start
2007-04-09
Project End
2010-03-31
Budget Start
2007-04-09
Budget End
2010-03-31
Support Year
1
Fiscal Year
2007
Total Cost
$311,818
Indirect Cost
Name
Craniotech Acr Devices, LLC
Department
Type
DUNS #
191068910
City
Dallas
State
TX
Country
United States
Zip Code
75214
Elsalanty, Mohammed E; Malavia, Veera; Zakhary, Ibrahim et al. (2015) Dentate transport discs can be used to reconstruct large segmental mandibular defects. J Oral Maxillofac Surg 73:745-58
Zapata, Uriel; Dechow, Paul C; Watanabe, Ikuya et al. (2014) Biomechanics of the canine mandible during bone transport distraction osteogenesis. J Biomech Eng 136:
Kontogiorgos, Elias; Elsalanty, Mohammed E; Zakhary, Ibrahim et al. (2013) Osseointegration of dental implants placed into canine mandibular bone regenerated by bone transport distraction osteogenesis. Int J Oral Maxillofac Implants 28:677-86
Zapata, Uriel; Halvachs, Emily K; Dechow, Paul C et al. (2011) Architecture and microstructure of cortical bone in reconstructed canine mandibles after bone transport distraction osteogenesis. Calcif Tissue Int 89:379-88
Zapata, Uriel; Opperman, Lynne A; Kontogiorgos, Elias et al. (2011) Biomechanical characteristics of regenerated cortical bone in the canine mandible. J Tissue Eng Regen Med 5:551-9
Zapata, Uriel; Elsalanty, Mohammed E; Dechow, Paul C et al. (2010) Biomechanical configurations of mandibular transport distraction osteogenesis devices. Tissue Eng Part B Rev 16:273-83