Point of Care, High Resolution and 3-Dimensional Ultrasonography

Study Overview
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Brief Summary
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The overall purpose of this study is to establish an ultrasound technique to aid in oral and dental examination of soft and hard tissues. Ultrasound is currently not used in Dentistry and associated oral examinations and we are exploring its usefulness for clinical practice. This study will investigate the use of ultrasonic imaging for planning and placing dental implants, as well as evaluate the use of ultrasonic imaging for monitoring marginal bone loss around dental implants.

Official Title
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Point of Care, High Resolution and 3-Dimensional Ultrasonography for Diagnosing Peri-Implant Bone Loss

Conditions
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Bone Loss in Jaw, Dental Diseases

Intervention / Treatment
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* Diagnostic Test: Ultrasound Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older • Have a dental implant infection (bleeding on probing/exudate and probing depths of at least 5 mm) and are or will be scheduled for revision surgery within 90 days of the screening visit. Willing to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: Unwilling or unable to read and sign informed consent form. Pregnancy or unsure of their pregnancy status (self-reported)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dental Implant Surgery<br>Subjects scheduled for a revision surgery after developing infection after implant surgery | Diagnostic Test: Ultrasound Scan<br>* Within 90 days before the revision surgery, a calibrated examiner will ultrasonically scan the implants. The ultrasound device has been validated for its usability and design on human subjects in our recent clinical study (the University of Michigan Institutional Review Board under the number HUM00139630 and was registered with the National Institutes of Health U.S. National Library of Medicine database for clinical trials (clinicaltrials.gov) under the following identifier: NCT03558282) Coupling will be achieved with commercially available sterilized US gel (Sterile Aquasonic, Fairfield, NJ). The US probe will be mounted on an adjustable arm attached to a fixed stand. The probe is navigated by a calibrated examiner at the implant of interest and then will execute a total ±5 mm linear mesio-distal and coronal-apical translations to create 3D cross-sectional and transverse volumes, respectively and stored as an imageframe series, i.e., a DICOM format cineloop.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Implant bone level | The difference between ultrasound-determined measurements and intraoperative measurements (optical scanner images as indirect measurements) | Within 90 days before dental surgery | 
| Dental implant radicular bone thickness | The difference between ultrasound-determined measurements and intraoperative measurements (optical scanner images as indirect measurements) | Within 90 days before dental surgery |