Point of Care, High Resolution and 3-Dimensional Ultrasonography

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.

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Key information

Conditions

Bone Loss in Jaw Dental Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ultrasound scan

Diagnostic Test

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.

Primary outcomes

Dental Implant bone level

Time frame: Within 90 days before dental surgery

The difference between ultrasound-determined measurements and intraoperative measurements (optical scanner images as indirect measurements)
Dental implant radicular bone thickness

Time frame: Within 90 days before dental surgery

The difference between ultrasound-determined measurements and intraoperative measurements (optical scanner images as indirect measurements)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Mar 16, 2022
Registry last updated: Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed