Point of Care, High Resolution and 3-Dimensional Ultrasonography

Dental Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05282212
• Other study ID #: HUM00170906
• Status: Completed
• Start date: March 9, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Loss in Jaw
• Dental Diseases
• Stomatognathic Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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