# A Smart Sensing Drill to Reduce Incidence of Dental Implant Complications

> **NIH NIH R42** · RYTEK MEDICAL, INC. · 2020 · $861,678

## Abstract

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 surgeon’s objective is to drill into the bone’s 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...

## Key facts

- **NIH application ID:** 9989828
- **Project number:** 5R42DE028209-03
- **Recipient organization:** RYTEK MEDICAL, INC.
- **Principal Investigator:** Ryan Joseph Halter
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $861,678
- **Award type:** 5
- **Project period:** 2018-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9989828

## Citation

> US National Institutes of Health, RePORTER application 9989828, A Smart Sensing Drill to Reduce Incidence of Dental Implant Complications (5R42DE028209-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9989828. Licensed CC0.

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