UltrasonographyNCT04487379
Ultrasound Crestal Bone Topography of Edentulous Ridges
An observational study of Ultrasonography, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ultrasonography
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
- Conditions
- Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 months after image was taken
Secondary outcomes (1)
Accuracy of ultrasound for assessing ridge surface quality
Evaluate the crestal bone surface quality with ultrasound
Measured: up to 3 months after image was taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start16 Jun 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsun-Liang Chan, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487379
- Sponsor's protocol ID
- HUM00183733
- Status last verified
- Jan 2021
- First submitted
- 17 Jul 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Crestal Bone Topography of Edentulous Ridges: A Retrospective Study Comparing Ultrasonography to Cone-Beam Computed Tomography (CBCT)
- ClinicalTrials.gov ID
- NCT04487379
- Acronym / sponsor ID
- HUM00183733
- Conditions
- Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Accuracy of ultrasound for assessing ridge surface quality
Time frame: up to 3 months after image was taken
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No. Not plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ultrasound for estimating ridge width (time frame: up to 3 months after image was taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.