| NSF Org: |
TI Translational Impacts |
| Recipient: |
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| Initial Amendment Date: | June 3, 2021 |
| Latest Amendment Date: | June 3, 2021 |
| Award Number: | 2129540 |
| Award Instrument: | Standard Grant |
| Program Manager: |
Ruth Shuman
rshuman@nsf.gov (703)292-2160 TI Translational Impacts TIP Directorate for Technology, Innovation, and Partnerships |
| Start Date: | June 1, 2021 |
| End Date: | November 30, 2021 (Estimated) |
| Total Intended Award Amount: | $50,000.00 |
| Total Awarded Amount to Date: | $50,000.00 |
| Funds Obligated to Date: |
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| History of Investigator: |
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| Recipient Sponsored Research Office: |
9500 GILMAN DR LA JOLLA CA US 92093-0021 (858)534-4896 |
| Sponsor Congressional District: |
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| Primary Place of Performance: |
9500 Gilman Drive La Jolla CA US 92093-0934 |
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Performance Congressional District: |
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| Unique Entity Identifier (UEI): |
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| Parent UEI: |
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| NSF Program(s): | I-Corps |
| Primary Program Source: |
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| Program Element Code(s): |
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| Award Agency Code: | 4900 |
| Fund Agency Code: | 4900 |
| Assistance Listing Number(s): | 47.084 |
ABSTRACT
The broader impact/commercial potential of this I-Corps project may lead to an accurate and early detection of periodontal disease to reduce the pain and cost of dental care. Periodontal disease is common and often results in dental pain, tooth loss, reduced quality of life, and even systemic effects like cardiovascular disease. The current methods for periodontal evaluation use manual probing and visual inspection. These methods are often inaccurate and have poor reproducibility, as well as being time consuming and sometimes painful. While X-ray imaging captures detailed information about intra-oral hard tissues, more detailed information about soft tissue is missed. There is an essential unmet need for non-invasive imaging to assess dental health. This project will improve periodontal evaluation and diagnostics, treatment planning, and therapy monitoring. It may also make dental exams less painful for patients and more accurate for dentists.
This I-Corps project develops a novel non-invasive periodontal imaging device that provides key information for periodontitis diagnosis. Dual modality ultrasound and photoacoustic imaging can be used as a superior alternative to the current standard of care for periodontal evaluation. This approach combines the resolution of ultrasound with the contrast and spectral behavior of optics. Photoacoustic imaging of the gingiva can detail the contours of the entire pocket with markedly less variability than conventional probing. This modality offers a perspective for early diagnosis of inflammation which is inaccessible by direct visual clinical assessment. In addition, ultrasound imaging can quantify gingival thickness which in turn, determines the final aesthetic treatment outcome. Current clinical attachment loss is visually measured based on cementoenamel junction (CEJ) location and it is only visible if gingival margin has already recessed due to disease. In contrast, the ultrasound approach can image anatomical landmarks including CEJ and gingival margin to quantify attachment loss. The successful demonstration of the proposed project may lead to an accurate diagnosis of gum disease in the early stage of gingivitis that reduces the risk of advanced periodontitis and tooth loss.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
PROJECT OUTCOMES REPORT
Disclaimer
This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.
This is an NSF iCORP project. The outcomes are new insights into the market.
StyloSonic’s mission is to improve oral healthcare. We are commercializing a novel non-invasive periodontal imaging device that helps dentists and periodontists in the diagnosis of gum disease in a faster, more repeatable, and more accurate way. We sent more than 500 emails, 600 LinkedIn messages, and 50 phone calls to dentists, periodontists, hygienists, dental office managers, dental insurances, and dental industry business owners to request interviews. We conducted 100 interviews during this project. Here are the main outcomes of our interviews:
- The primary market includes dentists and periodontal specialists. This is our beach-head market as the customers in this sector have the most critical need for what our technology provides with no other options to achieve their objectives. Both dentists and specialists are dissatisfied with the existing method (manual probing and visual inspection). It is invasive, slow, and inaccurate. The archetype customer profile will be dentists and specialists in private practices and academic institutes. The decision-maker is the private practice owner, and the end users are likely hygienists and dental technicians.
- One very important lesson from the interviews was that the number one lawsuit in the dental industry is mis-diagnosis of periodontal disease. After researching and interviewing more hygienists, they mentioned that they only have 30 to 45 minutes for each patient for annual checkups including X-ray, periodontal evaluation, and normal cleaning. They usually do not have sufficient time to perform a full evaluation, which leads to a lack of complete periodontal evaluation data.
-Periodontal assessments are commonly performed by dentists and specialists using a periodontal probe. This time-consuming process has remained largely unchanged for over 100 years. It suffers from poor reproducibility due to variation in probing force. Other sources of error include variation in the insertion point, probe angulation, the patient’s overall gingival health (e.g., weakly inflamed tissue) and the presence of calculus. Thus, the exam is subject to large errors with inter-operator variation as high as 40%. These errors can hamper clinical decision-making and epidemiological studies ultimately resulting in poor patient outcomes. After conducting more than 100 interviews with key opinion leaders in the dental industry, 97% agreed that the current standard of care (manual probing) is time-consuming (20 to 30 minutes), inaccurate (+/- 1 mm), unrepeatable (variation as high as 40%), and provides a subjective measurement. Moreover, 95% indicated that they are willing to pay up to $30,000 for an imaging device that can perform this periodontal examination quickly with higher accuracy and repeatability.
-It is important to describe an example of digital transition in dental industry. Dentists used to utilize manual impression for implants and orthodontics; this approach only cost $5. After the emergence of the intraoral scanner, there was a significant shift by dentists to use this new technology rather than the original manual impression technique. Even though these scanners are in the range of $30,000-$50,000, dentists realized that with the adoption of this new technology, they could reduce their chair time, which would in turn lead to higher overall revenue for the dental office due to more patients and more transactions. While the manual impression is as accurate as the intraoral scanner, dentists still adapted this new and revolutionary intraoral scanner.
Last Modified: 01/30/2022
Modified by: Jesse V Jokerst
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