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Periodontal Ultrasound/Photoacoustic Imaging (PUPI)

Award Number: R43DE031196
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2022

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Periodontal Ultrasound/Photoacoustic Imaging (PUPI) - 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 > 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 <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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	STYLOSONIC LLC	21141 CALLE DE PASEO	LAKE FOREST	CA	92630	ORANGE	USA	Oral Diseases and Disorders Research	000	1	4/3/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	STYLOSONIC LLC	21141 CALLE DE PASEO	LAKE FOREST	CA	92630	ORANGE	USA	Oral Diseases and Disorders Research	000	1	10/28/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $281,523 )
2021	2021	STYLOSONIC LLC	9175 JUDICIAL DR APT 6324	SAN DIEGO	CA	92122	SAN DIEGO	USA	Oral Diseases and Disorders Research	000	1	8/20/2021	NEW	$281,523
														Subtotal = $281,523

Grand Total All Awards = $281,523

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Periodontal Ultrasound/Photoacoustic Imaging (PUPI)

Award Number: R43DE031196

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2022

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