Sonographic Imaging of Oral and Dental Anatomical Structures (A Pilot Study)

August 31, 2018 updated by: Hsun-Liang Chan, University of Michigan
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 its usefulness for clinical practice will be explored. 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

Detailed Description

This study will involve two different groups of subjects: Patients scheduled for a dental implant procedure, and patients scheduled for a revision surgery after developing infection after implant surgery.

Twenty subjects examining only specific aim one is funded and will be studied. If future funding is granted and additional 30 subjects for aim one and 40 for aim two will be studied Subjects in both groups will receive an ultrasound examination of the oral cavity prior to their clinically-scheduled dental surgery. Subjects in group 1 also may receive a CBCT scan if not previously clinically-ordered.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects 18 years of age and older who will be scheduled to have an implant surgery from premolar to premolar with bilateral adjacent teeth present will be recruited.

Description

Inclusion Criteria:

  • Subjects 18 years of age and older who will be scheduled to have an implant surgery from premolar to premolar with bilateral adjacent teeth present will be recruited.

Exclusion Criteria:

  • Patients under 18 years of age.
  • Unwilling or unable to read and sign this informed consent document.
  • Do not have a tooth on each side of the implant that will be placed.
  • Women who are pregnant or unsure of their pregnancy status.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients with 1 missing tooth
Patients with 1 missing anterior or premolar tooth and planned for implant surgery were recruited. Gingiva and alveolar bone were ultrasound scanned and compared to CT scans and direct measures during implant surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ultrasound soft tissue thickness
Time Frame: At least 6 months after implant crown placement (1 time point)
soft tissue thickness at the missing tooth gap and adjacent teeth were measured with ultrasound
At least 6 months after implant crown placement (1 time point)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ultrasound alveolar bone height
Time Frame: At least 6 months after implant crown placement (1 time point)
alveolar bone height at the missing tooth gap and adjacent teeth was measured
At least 6 months after implant crown placement (1 time point)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Delta Dental Foundation
MICHR Pilot grant (UL1TR000433)
POM Supplemental Grant
SOD Collision Award
AAP's SUNSTAR Innovation Grant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2017

Primary Completion (Actual)

January 16, 2018

Study Completion (Actual)

January 16, 2018

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00099062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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