Project Grant R43DE031196

Award Date 9/1/21
Completion Date 8/31/22
Dollars Obligated $845K
Federal Grant Program
93.121
Assistance Type
Project Grant
Place of Performance
California, USA
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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

Posted 8/20/21, 12:00 AM