UltrasoundNCT03657589
Sonographic Imaging of Oral and Dental Anatomical Structures (A Pilot Study)
An observational study of Ultrasound and Oral Mucosa, 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 its usefulness for clinical practice will be explored. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, Oral Mucosa, Gingival Recession
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 16 Jan 2018
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects 18 years of age and older who will be scheduled to have an implant surgery from premolar to premolar with bilateral adjacent teeth present will be recruited.
Who may be able to join
- Subjects 18 years of age and older who will be scheduled to have an implant surgery from premolar to premolar with bilateral adjacent teeth present will be recruited.
Who cannot join
- Patients under 18 years of age.
- Unwilling or unable to read and sign this informed consent document.
- Do not have a tooth on each side of the implant that will be placed.
- Women who are pregnant or unsure of their pregnancy status.
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
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 its usefulness for clinical practice will be explored. 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.
Read the detailed description
This study will involve two different groups of subjects: Patients scheduled for a dental implant procedure, and patients scheduled for a revision surgery after developing infection after implant surgery.
Twenty subjects examining only specific aim one is funded and will be studied. If future funding is granted and additional 30 subjects for aim one and 40 for aim two will be studied Subjects in both groups will receive an ultrasound examination of the oral cavity prior to their clinically-scheduled dental surgery. Subjects in group 1 also may receive a CBCT scan if not previously clinically-ordered.
- Conditions
- Ultrasound, Oral Mucosa, Gingival Recession, Alveolar Bone Loss
- Medical subject headings
- Gingival Recession, Alveolar Bone Loss
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 |
|---|---|---|
| patients with 1 missing tooth | Patients with 1 missing anterior or premolar tooth and planned for implant surgery were recruited. Gingiva and alveolar bone were ultrasound scanned and compared to CT scans and direct measures during implant surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound soft tissue thickness
soft tissue thickness at the missing tooth gap and adjacent teeth were measured with ultrasound
Measured: At least 6 months after implant crown placement (1 time point)
Secondary outcomes (1)
ultrasound alveolar bone height
alveolar bone height at the missing tooth gap and adjacent teeth was measured
Measured: At least 6 months after implant crown placement (1 time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start22 Feb 2017
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- MICHR Pilot grant (UL1TR000433), Delta Dental Foundation, POM Supplemental Grant, SOD Collision Award, AAP's SUNSTAR Innovation Grant
- Responsible party
- Principal investigator, Hsun-Liang Chan, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657589
- Sponsor's protocol ID
- HUM00099062
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhaskar V, Chan HL, MacEachern M, Kripfgans OD. Updates on ultrasound research in implant dentistry: a systematic review of potential clinical indications. Dentomaxillofac Radiol. 2018 Jul;47(6):20180076. doi: 10.1259/dmfr.20180076. Epub 2018 Jun 6.
PubMed 29791198Chan HL, Sinjab K, Li J, Chen Z, Wang HL, Kripfgans OD. Ultrasonography for noninvasive and real-time evaluation of peri-implant tissue dimensions. J Clin Periodontol. 2018 Aug;45(8):986-995. doi: 10.1111/jcpe.12918. Epub 2018 Jun 25.
PubMed 29757464Chan HL, Sinjab K, Chung MP, Chiang YC, Wang HL, Giannobile WV, Kripfgans OD. Non-invasive evaluation of facial crestal bone with ultrasonography. PLoS One. 2017 Feb 8;12(2):e0171237. doi: 10.1371/journal.pone.0171237. eCollection 2017.
PubMed 28178323Chung MP, Wang IC, Chan HL, Wang HL. Evaluation of Buccal Bone Concavity in the Esthetic Zone: A Cadaver Study. Implant Dent. 2017 Oct;26(5):751-755. doi: 10.1097/ID.0000000000000661.
PubMed 28914631Fu JH, Yeh CY, Chan HL, Tatarakis N, Leong DJ, Wang HL. Tissue biotype and its relation to the underlying bone morphology. J Periodontol. 2010 Apr;81(4):569-74. doi: 10.1902/jop.2009.090591.
PubMed 20367099
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Imaging of Oral and Dental Anatomical Structures (A Pilot Study)
- ClinicalTrials.gov ID
- NCT03657589
- Acronym / sponsor ID
- HUM00099062
- Conditions
- Ultrasound, Oral Mucosa, Gingival Recession, Alveolar Bone Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- MICHR Pilot grant (UL1TR000433), Delta Dental Foundation, POM Supplemental Grant, SOD Collision Award, AAP's SUNSTAR Innovation Grant
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 5 Sep 2018 (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 its usefulness for clinical practice will be explored. 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.
Detailed description
This study will involve two different groups of subjects: Patients scheduled for a dental implant procedure, and patients scheduled for a revision surgery after developing infection after implant surgery.
Twenty subjects examining only specific aim one is funded and will be studied. If future funding is granted and additional 30 subjects for aim one and 40 for aim two will be studied Subjects in both groups will receive an ultrasound examination of the oral cavity prior to their clinically-scheduled dental surgery. Subjects in group 1 also may receive a CBCT scan if not previously clinically-ordered.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with 1 missing tooth | – | –Patients with 1 missing anterior or premolar tooth and planned for implant surgery were recruited. Gingiva and alveolar bone were ultrasound scanned and compared to CT scans and direct measures during implant surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years of age and older who will be scheduled to have an implant surgery from premolar to premolar with bilateral adjacent teeth present will be recruited.
Key inclusion criteria (1 listed)
- Subjects 18 years of age and older who will be scheduled to have an implant surgery from premolar to premolar with bilateral adjacent teeth present will be recruited.
Key exclusion criteria (4 listed)
- Patients under 18 years of age.
- Unwilling or unable to read and sign this informed consent document.
- Do not have a tooth on each side of the implant that will be placed.
- Women who are pregnant or unsure of their pregnancy status.
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
ultrasound soft tissue thickness
Time frame: At least 6 months after implant crown placement (1 time point)
soft tissue thickness at the missing tooth gap and adjacent teeth were measured with ultrasound
1 secondary outcome
ultrasound alveolar bone height
Time frame: At least 6 months after implant crown placement (1 time point)
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 5 Sep 2018.
- Background: PubMed 29791198Bhaskar V, Chan HL, MacEachern M, Kripfgans OD. Updates on ultrasound research in implant dentistry: a systematic review of potential clinical indications. Dentomaxillofac Radiol. 2018 Jul;47(6):20180076. doi: 10.1259/dmfr.20180076. Epub 2018 Jun 6.
- Background: PubMed 29757464Chan HL, Sinjab K, Li J, Chen Z, Wang HL, Kripfgans OD. Ultrasonography for noninvasive and real-time evaluation of peri-implant tissue dimensions. J Clin Periodontol. 2018 Aug;45(8):986-995. doi: 10.1111/jcpe.12918. Epub 2018 Jun 25.
- Background: PubMed 28178323Chan HL, Sinjab K, Chung MP, Chiang YC, Wang HL, Giannobile WV, Kripfgans OD. Non-invasive evaluation of facial crestal bone with ultrasonography. PLoS One. 2017 Feb 8;12(2):e0171237. doi: 10.1371/journal.pone.0171237. eCollection 2017.
- Background: PubMed 28914631Chung MP, Wang IC, Chan HL, Wang HL. Evaluation of Buccal Bone Concavity in the Esthetic Zone: A Cadaver Study. Implant Dent. 2017 Oct;26(5):751-755. doi: 10.1097/ID.0000000000000661.
- Background: PubMed 20367099Fu JH, Yeh CY, Chan HL, Tatarakis N, Leong DJ, Wang HL. Tissue biotype and its relation to the underlying bone morphology. J Periodontol. 2010 Apr;81(4):569-74. doi: 10.1902/jop.2009.090591.
- Individual participant dataSharing planned: No
Related trials for Ultrasound
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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 Ultrasound and Oral Mucosa, 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 4 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 5 Sep 2018. 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?
ultrasound soft tissue thickness (time frame: At least 6 months after implant crown placement (1 time point)). 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 NCT03657589, which also lists 5 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 5 Sep 2018.