UltrasonographyNCT04488302
Ultrasonography and Cone-Beam Computed Tomography for Peri-implant Tissue Evaluation
An observational study of Ultrasonography, run by University of Michigan at 1 site in United States.
Trial summary
Objectives: Although cone-beam computed tomography (CBCT) is becoming a standard of care in implant therapy, concerns have been raised recently about its limitation in imaging peri-implant tissues due to artifacts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ultrasonography
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 7 Jul 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
- Child, Adult, Older adult
Study population: See eligibility criteria
Who may be able to join
- the patients had to have ≥ 1 implant with a CBCT scan, US scan, and clinical photographs taken during the surgery, e.g. a revision/explantation surgery due to peri-implantitis or a 2nd stage uncover surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study on Use of Ultrasonography and Cone-Beam Computed Tomography for Evaluating Peri-implant Tissue
Objectives: Although cone-beam computed tomography (CBCT) is becoming a standard of care in implant therapy, concerns have been raised recently about its limitation in imaging peri-implant tissues due to artifacts. The aim of present study was to demonstrate the complementary role of ultrasound (US), for a comprehensive examination of peri-implant tissues in live humans. Material and Methods: Patients with > 1 implant, a CBCT scan, an US scan, and clinical photographs taken during the open-bone surgery were included. The crestal bone thickness (CBT) and facial bone level (FBL) were measured on both modalities, and direct FBL measurements were also made on clinical images. The correlation plots were made to evaluate the measurement agreements between the 3 methods.
- 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 |
|---|---|---|
| Implant group | Patients with 1 or more implants with CBCT, ultrasound and open-bone images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone thickness
facial bone thickness measured at 1 mm apical to bone crest
Measured: up to 100 months after implant surgery.
Secondary outcomes (1)
Facial bone height
facial bone height measured from implant platform
Measured: up to 100 months after implant surgery.
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 start1 Nov 2019
- Primary completion30 May 2020
- Study completion7 Jul 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
- Retrospective
- Enrolment
- 4 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
- NCT04488302
- Sponsor's protocol ID
- HUM00179671
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No share with others
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Use of Ultrasonography and Cone-Beam Computed Tomography for Evaluating Peri-implant Tissue
- ClinicalTrials.gov ID
- NCT04488302
- Acronym / sponsor ID
- HUM00179671
- Conditions
- Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 7 Jul 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.
Objectives: Although cone-beam computed tomography (CBCT) is becoming a standard of care in implant therapy, concerns have been raised recently about its limitation in imaging peri-implant tissues due to artifacts. The aim of present study was to demonstrate the complementary role of ultrasound (US), for a comprehensive examination of peri-implant tissues in live humans. Material and Methods: Patients with > 1 implant, a CBCT scan, an US scan, and clinical photographs taken during the open-bone surgery were included. The crestal bone thickness (CBT) and facial bone level (FBL) were measured on both modalities, and direct FBL measurements were also made on clinical images. The correlation plots were made to evaluate the measurement agreements between the 3 methods.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant group | – | –Patients with 1 or more implants with CBCT, ultrasound and open-bone images |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- See eligibility criteria
Key inclusion criteria (1 listed)
- the patients had to have ≥ 1 implant with a CBCT scan, US scan, and clinical photographs taken during the surgery, e.g. a revision/explantation surgery due to peri-implantitis or a 2nd stage uncover surgery.
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
Crestal bone thickness
Time frame: up to 100 months after implant surgery.
facial bone thickness measured at 1 mm apical to bone crest
1 secondary outcome
Facial bone height
Time frame: up to 100 months after implant surgery.
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 13 Apr 2026.
- Individual participant dataSharing planned: No. No share with others
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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 1 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 13 Apr 2026. 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?
Crestal bone thickness (time frame: up to 100 months after implant surgery.). 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 13 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.