Point of Care, High Resolution and 3-Dimensional Ultrasonography

Completed

• Conditions: Bone Loss in Jaw; Dental Diseases
• Interventions: Diagnostic Test: Ultrasound Scan

• Registration Number: NCT05282212
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-07
• Study Start: 2022-03-09
• Study First Posted: 2022-03-16
• Primary Completion: 2023-03-31
• Study Completion: 2023-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dental Implant Surgery	Ultrasound Scan	Subjects scheduled for a revision surgery after developing infection after implant surgery

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States