Point of Care, High Resolution and 3-Dimensional Ultrasonography

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Diseases; Bone Loss in Jaw
• Intervention / Treatment: Diagnostic test: Ultrasound Scan

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

• Study Contact: Name: Hsun-Liang Chan, DDS, MS; Phone Number: 7347633325; Email: hlchan@umich.edu
• Study Contact Backup: Name: Alice Ou, RDH, MS; Phone Number: 7347633346; Email: aliceou@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients at the University of Michigan School of Dentistry who are scheduled for dental implant revision surgery as standard of care in the Graduate Periodontics department.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Dental Implant Surgery; Subjects scheduled for a revision surgery after developing infection after implant surgery

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Hsun-Liang Chan, DDS, MS, University of Michigan; Principal Investigator: Oliver Kripfgans, PhD, University of Michigan, Radiology

Publications and helpful links

General Publications

• Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available.
• Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
• Chan HL, Misch K, Wang HL. Dental imaging in implant treatment planning. Implant Dent. 2010 Aug;19(4):288-98. doi: 10.1097/ID.0b013e3181e59ebd.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases
• Other Study ID Numbers: HUM00170906

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No