NCT04487379

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

June 16, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

July 17, 2020

Last Update Submit

January 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of ultrasound for estimating ridge width

    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 Outcomes (1)

  • Accuracy of ultrasound for assessing ridge surface quality

    up to 3 months after image was taken

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 27, 2020

Study Start

June 16, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Not plan to share IPD.

Locations