- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04487379
Ultrasound Crestal Bone Topography of Edentulous Ridges
January 13, 2021 updated by: Hsun-Liang Chan, University of Michigan
Evaluation of Crestal Bone Topography of Edentulous Ridges: A Retrospective Study Comparing Ultrasonography to Cone-Beam Computed Tomography (CBCT)
A successful implant surgery primarily relies on a prudent evaluation of oral anatomy and meticulous treatment planning.
Additionally, of paramount importance that dictates the types of procedures, material selection and ultimately success of implant surgery is the quality and quantity of the edentulous ridge.
Ultrasound imaging (US), another cross-sectional imaging modality, has been extensively used in the medical diagnostics field.
The ability of ultrasound to image soft tissue-bone interface makes it particularly promising for studying bone ridge width and crestal bone topography.
Therefore, this retrospective human study aimed to compare bone width measurements between US and CBCT.
This study also investigated the possible correlation between the crestal bone surface quality imaged by US and CBCT.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
28
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
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Records of patients who had at least 1 edentulous ridge with a plan for implant placement, had cone-beam computed tomography as standard procedure and ultrasound imaging for off-label use of evaluating the ridge were included.
Description
Inclusion Criteria:
- Patient records at the Graduate Periodontal Clinic
- With both US and CBCT scans taking within 3 months between each other from Jan 2016 to Mar 2020
- These images had to include at least one edentulous ridge at the anterior, premolar or molar site.
- Multiple sites in a given patient may be included.
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
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
|
Group with edentulous ridge
This group had edentulous ridge planning to receive a dental implant and had ultrasound and cone-beam computed tomography images of the ridge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of ultrasound for estimating ridge width
Time Frame: up to 3 months after image was taken
|
measure the edentulous ridge width at 1, 2 and 3 mm apical to the crest on ultrasound images
|
up to 3 months after image was taken
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of ultrasound for assessing ridge surface quality
Time Frame: up to 3 months after image was taken
|
Evaluate the crestal bone surface quality with ultrasound
|
up to 3 months after image was taken
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 16, 2020
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
July 17, 2020
First Submitted That Met QC Criteria
July 22, 2020
First Posted (Actual)
July 27, 2020
Study Record Updates
Last Update Posted (Actual)
January 15, 2021
Last Update Submitted That Met QC Criteria
January 13, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00183733
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Not plan to share IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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