Point of Care, High Resolution and 3-Dimensional Ultrasonography

CompletedOBSERVATIONAL
Enrollment

41

Participants

Timeline

Start Date

March 9, 2022

Primary Completion Date

March 31, 2023

Study Completion Date

August 31, 2023

Conditions
Bone Loss in JawDental Diseases
Interventions
DIAGNOSTIC_TEST

Ultrasound Scan

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.

Trial Locations (1)

48108

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

University of Michigan

OTHER