NCT05282212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

March 9, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

March 7, 2022

Last Update Submit

October 17, 2023

Conditions

Bone Loss in JawDental Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Dental Implant Surgery

Subjects scheduled for a revision surgery after developing infection after implant surgery

Diagnostic Test: Ultrasound Scan

Interventions

Ultrasound ScanDIAGNOSTIC_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.

Dental Implant Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Unwilling or unable to read and sign informed consent form.
  • Pregnancy or unsure of their pregnancy status (self-reported)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Related 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.

    PMID: 20683285BACKGROUND

  • 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.

    PMID: 18724855BACKGROUND

  • 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.

    PMID: 23537178BACKGROUND

MeSH Terms

Conditions

Stomatognathic Diseases

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hsun-Liang Chan, DDS, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Oliver Kripfgans, PhD

    University of Michigan, Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Program Director, Periodontics Graduate Program

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

March 9, 2022

Primary Completion

March 31, 2023

Study Completion

August 31, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

US(1)