SBIR/STTR Research Award

Periodontal Ultrasound/Photoacoustic Imaging (PUPI)

Award identifier 983aa6d13f6ce22ccc0b88daaa05d58cd7f0434e04076e7a08af0bf93af88f61Awarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$281,523

Program and phase

SBIR · Phase I

Award year

2021

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
STYLOSONIC LLC
Proposal award date
2021-09-01
Contract end date
2022-08-31
UEI
ZBEKC9AMDEB3
Solicitation number
PA19-022
Topic code
NIDCR

Research abstract

PROJECT SUMMARY The objective of this proposal is to design and validate a Periodontal Ultrasound/Photoacoustic Imaging (PUPI) device which can non-invasively measure periodontal pocket depth, clinical attachment loss based on cementoenamel junction (CEJ) location, gingival biotype and inflammation. Current periodontal evaluation methods are inaccurate because they are based on visual inspection and periodontal probing. While radiography offers detailed information about hard tissues such as bone and teeth, more detailed information about soft tissue is usually missed in radiography. Ultrasound/photoacoustic approach has been used in soft tissue imaging but rarely in dentistry because they have a large size transducer which limits the entire oral cavity scan. This is a fundamental limitation of existing technology. To solve this problem, StyloSonic LLC will construct and validate a miniaturized handpiece with a compact laser diode for ultrasound/photoacoustic imaging to provide key periodontal metrics. PUPI offers real-time, accurate, and repeatable measurements with utility in diagnosis and therapy monitoring. That is the value of this proposal. The workflow will include two parts: Aim 1 will design and fabricate the PUPI prototype and Aim 2 will evaluate the fundamental functionality of the device and confirm the validation in a pilot clinical study in collaboration with Dr. Casey Chen at University of Southern California. 100 teeth (5-10 patients) with moderate periodontitis (pocket depth: 4-6 mm) will be evaluated with PUPI and manual probing method before and 4-week after the nonsurgical treatment (i.e., scaling and root planning). That will give us 80% statistical power assuming an alpha of 0.05 based on our preliminary data. Our goal is to build a handpiece that can easily scan the entire oral cavity. We will test the designed miniaturized handpiece using an oral care manikin. We hypothesize that the correlation coefficient between probing and PUPI is R2 andgt; 0.8. We also hypothesize that the PUPI will show a significant difference in pocket depth, clinical attachment loss, gingival biotype and inflammation before and four weeks after treatment (p andlt;0.05). This approach is innovative because for the first time, the miniaturized handpiece of PUPI will provide anatomical and functional information of the entire gingiva architecture. In addition, PUPI will enable accurate diagnostics and therapy monitoring which add enormous value for recommended treatment and ensure best outcomes. The clinical impact is the proposed device will assist dentists and periodontists to accurately diagnose gingivitis in the early stage and reduce the rate of advanced periodontitis. This work will introduce a non-invasive and non- ionizing dual modality imaging technique which has significant impacts on oral health care.PROJECT NARRATIVE Dental health is critical to quality of life, but the tools that dentists use for periodontal exams are largely anatomical and inspect the gingiva by eye or periodontal charting. This work will develop and validate a non- invasive Periodontal Ultrasound/Photoacoustic Imaging (PUPI) with a miniaturized handpiece. This will facilitate accurate early diagnosis of periodontitis which leads to the improvement of the treatment and ensures best outcomes.

Technology keywords

Not reported

Other awards by this recipient

Verified by the same UEI. These are other public SBIR/STTR award pages, not a merged company record.

Awards with the same topic code

Verified by an exact topic code match. This is not a text-similarity match.

Research funding history

2 SBIR/STTR records share this UEI (2021–2022). Reported award amounts total $537,280. Reported amounts are not federal obligations.

Phases: Phase I

Agencies: Department of Health and Human Services, National Science Foundation

Agency intelligence

Department of Health and Human Services

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