Bone Loss in JawNCT05282212
Point of Care, High Resolution and 3-Dimensional Ultrasonography
An observational study of Bone Loss in Jaw and Dental Diseases, run by University of Michigan at 1 site in United States.
Trial summary
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 we are exploring its usefulness for clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss in Jaw, Dental Diseases
- What is being tested?
- Ultrasound Scan
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 31 Aug 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at the University of Michigan School of Dentistry who are scheduled for dental implant revision surgery as standard of care in the Graduate Periodontics department.
Who may be able to join
- Aged 18 years or older
- • Have a dental implant infection (bleeding on probing/exudate and probing depths of at least 5 mm) and are or will be scheduled for revision surgery within 90 days of the screening visit.
- Willing to comply with all study procedures and be available for the duration of the study.
Who cannot join
- Unwilling or unable to read and sign informed consent form.
- Pregnancy or unsure of their pregnancy status (self-reported)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point of Care, High Resolution and 3-Dimensional Ultrasonography for Diagnosing Peri-Implant Bone Loss
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 we are exploring its usefulness for clinical practice. 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.
- Conditions
- Bone Loss in Jaw, Dental Diseases
- Being tested
- Ultrasound Scan
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ScanDiagnostic test
Within 90 days before the revision surgery, a calibrated examiner will ultrasonically scan the implants. The ultrasound device has been validated for its usability and design on human subjects in our recent clinical study (the University of Michigan Institutional Review Board under the number HUM00139630 and was registered with the National Institutes of Health U.S. National Library of Medicine database for clinical trials (clinicaltrials.gov) under the following identifier: NCT03558282) Coupling will be achieved with commercially available sterilized US gel (Sterile Aquasonic, Fairfield, NJ). The US probe will be mounted on an adjustable arm attached to a fixed stand. The probe is navigated by a calibrated examiner at the implant of interest and then will execute a total ±5 mm linear mesio-distal and coronal-apical translations to create 3D cross-sectional and transverse volumes, respectively and stored as an imageframe series, i.e., a DICOM format cineloop.
| Study group | Role | What they receive |
|---|---|---|
| Dental Implant Surgery | Subjects scheduled for a revision surgery after developing infection after implant surgery Receives: Diagnostic Test: Ultrasound Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Implant bone level
The difference between ultrasound-determined measurements and intraoperative measurements (optical scanner images as indirect measurements)
Measured: Within 90 days before dental surgery
Dental implant radicular bone thickness
The difference between ultrasound-determined measurements and intraoperative measurements (optical scanner images as indirect measurements)
Measured: Within 90 days before dental surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start9 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone Loss in JawStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Hsun-Liang Chan, University of Michigan
- Investigators
- Hsun-Liang Chan, DDS, MS, Principal investigator, University of MichiganOliver Kripfgans, PhD, Principal investigator, University of Michigan, Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282212
- Sponsor's protocol ID
- HUM00170906
- Status last verified
- Oct 2023
- First submitted
- 7 Mar 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan HL, Misch K, Wang HL. Dental imaging in implant treatment planning. Implant Dent. 2010 Aug;19(4):288-98. doi: 10.1097/ID.0b013e3181e59ebd.
PubMed 20683285Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
PubMed 18724855Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available.
PubMed 23537178
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care, High Resolution and 3-Dimensional Ultrasonography for Diagnosing Peri-Implant Bone Loss
- ClinicalTrials.gov ID
- NCT05282212
- Acronym / sponsor ID
- HUM00170906
- Conditions
- Bone Loss in Jaw, Dental Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 16 Mar 2022 (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.
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 we are exploring its usefulness for clinical practice. 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental Implant Surgery | – | Diagnostic Test: Ultrasound ScanSubjects scheduled for a revision surgery after developing infection after implant surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the University of Michigan School of Dentistry who are scheduled for dental implant revision surgery as standard of care in the Graduate Periodontics department.
Key inclusion criteria (3 listed)
- Aged 18 years or older
- • Have a dental implant infection (bleeding on probing/exudate and probing depths of at least 5 mm) and are or will be scheduled for revision surgery within 90 days of the screening visit.
- Willing to comply with all study procedures and be available for the duration of the study.
Key exclusion criteria (2 listed)
- Unwilling or unable to read and sign informed consent form.
- Pregnancy or unsure of their pregnancy status (self-reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ScanWithin 90 days before the revision surgery, a calibrated examiner will ultrasonically scan the implants. The ultrasound device has been validated for its usability and design on human subjects in our recent clinical study (the University of Michigan Institutional Review Board under the number HUM00139630 and was registered with the National Institutes of Health U.S. National Library of Medicine database for clinical trials (clinicaltrials.gov) under the following identifier: NCT03558282) Coupling will be achieved with commercially available sterilized US gel (Sterile Aquasonic, Fairfield, NJ). The US probe will be mounted on an adjustable arm attached to a fixed stand. The probe is navigated by a calibrated examiner at the implant of interest and then will execute a total ±5 mm linear mesio-distal and coronal-apical translations to create 3D cross-sectional and transverse volumes, respectively and stored as an imageframe series, i.e., a DICOM format cineloop. | Diagnostic test | Dental Implant Surgery |
Primary outcome
Dental Implant bone level
Time frame: Within 90 days before dental surgery
The difference between ultrasound-determined measurements and intraoperative measurements (optical scanner images as indirect measurements)
Dental implant radicular bone thickness
Time frame: Within 90 days before dental surgery
The difference between ultrasound-determined measurements and intraoperative measurements (optical scanner images as indirect measurements)
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 18 Oct 2023.
- Background: PubMed 20683285Chan HL, Misch K, Wang HL. Dental imaging in implant treatment planning. Implant Dent. 2010 Aug;19(4):288-98. doi: 10.1097/ID.0b013e3181e59ebd.
- Background: PubMed 18724855Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
- Background: PubMed 23537178Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available.
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Bone Loss in Jaw
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.
Hsun-Liang Chan, DDS, MS principal investigator
University of Michigan
Oliver Kripfgans, PhD principal investigator
University of Michigan, Radiology
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 Bone Loss in Jaw and Dental Diseases, 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 3 inclusion and 2 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 18 Oct 2023. 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?
Dental Implant bone level (time frame: Within 90 days before dental surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282212, which also lists 3 linked publications.
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 18 Oct 2023.