Phase II year
2019
(last award dollars: 2020)
Phase II Amount
$1,473,322
Clinical Importance: Almost 10 million dental implants were placed worldwide in 2016, with 3 million of these procedures taking place in the United States. The worldwide market for these implants is expected to increase to $4.0-$5.0 billion in revenue by 2018 as more patients opt for this procedure to regain chewing function and improve cosmetic appearance. The procedure itself requires an osteotomy be drilled into the mandible or maxilla (depending on site of implant) so that the implant can be seated within the boney structures of the jaw. A significant challenge to creating the initial osteotomy is ensuring that no critical structures near to the bone are breached leading to severe post-procedure morbidities. Clinical Limitations: The surgeons objective is to drill into the bones cancellous structure without breaching the cortical bone protecting critical anatomic structures. In the case of a mandibular implant, the inferior alveolar nerve (IAN) runs through the cancellous bone and innervates the teeth of the lower jaw, lips, gums, and skin overlying the chin. The IAN is protected by a conduit of cortical or dense cancellous bone; if breached during a drilling procedure, irreversible nerve injury is possible. In the case of maxillary implants, a cortical bone interface separates the cancellous bone of the maxilla from the maxillary sinus. Breaching the cortical bone in this case can lead to severe sinus complications. State-of-the art guidance systems have accuracies on the order of 2 mm, while current guidelines suggest a 1-2 mm margin of safety is needed around these critical interfaces. Currently, no existing technology is available to provide real-time guidance during drilling that alerts surgeons to an approaching critical anatomic structure. Our Product The OsteoSmartSense Drill System is a device that integrates with a standard dental drill, can be used with any current guidance system, and provides real-time electrical impedance sensing capabilities. The electrical impedance of cortical bone is significantly greater than that of the cancellous bone found within the mandible and maxilla. We hypothesize that electrical bioimpedance signatures recorded at the tip of the drill bit with OsteoSmartSense will be sufficiently sensitive and specific to detect when cortical bone structures (or nerve or blood vessel) are being approached (prior to breaching). Specific Objectives: We specifically propose to optimize the design of our OsteoSmartSense Drill System with controlled manufacturing processes and facilities in order to meet Current Good Manufacturing Practices (CGMPs) as is required for submitting a device application to the FDA. Secondly, we aim to optimize our detection algorithms and evaluate safety and efficacy in an in vivo animal model. Future Directions: RyTek Medical is a small company developing bioimpedance-sensing devices for a variety of clinical applications. This specific device will compliment our existing efforts. By the end of this program we will have demonstrated that the smart sensing drill is functional in an in vivo model. This will position us to submit a 510(k) or IDE application to the FDA in order to conduct first-inhuman trials. Additional uses of this technology might include identifying cracks in teeth (impedance of air is much greater that of dental tissue), identifying alveolar bone loss, or use in orthopedic drilling applications.
Public Health Relevance Statement: Dental implantation currently relies on pre-operative imaging technologies to help guide dental surgeons in safely drilling into the jaw to accurately position an implant; unfortunately, these pre-operative images do not provide real-time feedback during the drilling process resulting in the potential for serious post-surgical complications associated with drill penetration into critical anatomic structures (including nerve bundles and sinus cavities). We propose to optimize and commercialize our OsteoSmartSense Drill System, a smart sensing dental drill add-on that is capable of gauging tissue bioimpedance at the tip of the drill bit. This novel technology will provide real-time feedback regarding the position of the drill during the procedure and help dental surgeons to potentially avoid surgically-related patient injuries.
NIH Spending Category: Bioengineering; Dental/Oral and Craniofacial Disease
Project Terms: Air; Algorithms; Alveolar Bone Loss; Anatomy; Animal Model; Animals; Appearance; base; Blood Vessels; bone; Bone structure; Businesses; Clinical; clinical application; cohort; college; Computer Simulation; Computer software; Computers; cortical bone; Cosmetics; Dental; Dental Implantation; Dental Implants; design; Detection; Devices; Discrimination; electric impedance; electrical property; Electrodes; Ensure; ergonomics; Evaluation; experimental study; Failure; Family suidae; Feedback; Future; Guidelines; Human; Iatrogenesis; Image; Imaging technology; Implant; improved; in vivo; in vivo Model; Incidence; inferior alveolar nerve; Injury; Jaw; Lead; Legal patent; Letters; Lip structure; Mandible; mandible/maxilla; manufacturing facility; manufacturing process; Mastication; Maxilla; Maxillary Sinus; Measurement; Medical; millisecond; Modeling; Morbidity - disease rate; Nerve; nerve injury; neurosensory; new technology; novel; off-patent; Operative Surgical Procedures; Orthopedics; Osteotomy; Outcome; Patients; Penetration; Phase; Phase I Clinical Trials; Positioning Attribute; pre-clinical; Preparation; prevent; Procedures; Process; programs; Protocols documentation; prototype; Reporting; Resolution; Running; Safety; Sampling; Sensitivity and Specificity; sensor; Sinus; Site; Skin; Structure; substantia spongiosa; success; Surface; Surgeon; Surgical complication; System; Technology; Testing; Thinness; Time; Tissues; Titanium; tool; Tooth structure; Translating; United States
