Magnetic Resonance ImagingNCT03018158
MR Images Variation With or Without Denture Wear
A study testing denture wear. in people with Magnetic Resonance Imaging, run by Nihon University at 1 site in Japan.
Trial summary
The objective of this study was to compare level of artifact while tongue at rest and in motion of dentulous subjects. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- denture wear.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2016to Mar 2018
- Phase
- Interventional
- 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- dentulous
- edentulous classified Eichner' s classfication
Who cannot join
- involuntary motion occurs during imaging
- absolutely contraindicated or as a rule contraindicated of MRI examination
- subjects have ferromagnetic metals in the oral cavity
- subjects can not swallow naturally
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MR Images Variation With or Without Denture Wear. Motion Artifacts Related With Tongue Movements
The objective of this study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.
Read the detailed description
The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially to detect cancer and disk displacement with temporomandibular disorders. The prevalence of tongue cancer may increase with ageing population. A clear MR image is indispensable for clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be prominent with the patients without the occlusal support. The objective of this pilot study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- denture wear.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denture wear.Device
MR Imaging was collected with or without denture wear.
| Study group | Role | What they receive |
|---|---|---|
| dentulous | No intervention | MR Imaging was collected with condition at the tongue at rest position. |
| edentulous without denture wear. | No intervention | MR Imaging was collected without denture wear. |
| edentulous with denture wear. | Experimental | MR Imaging was collected with denture wear. Receives: Device: denture wear. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Luminance standard deviation value on MR image
Measured: MR Imaging was collected with each condition.Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasuhiko Kawai, Nihon University
- Investigators
- Yasuhiko Kawai, DDS MSc PhD, Study chair, Nihon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018158
- Sponsor's protocol ID
- EC 15-019
- Status last verified
- Apr 2018
- First submitted
- 28 Dec 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Images Variation With or Without Denture Wear. Motion Artifacts Related With Tongue Movements
- ClinicalTrials.gov ID
- NCT03018158
- Acronym / sponsor ID
- EC 15-019
- Conditions
- Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Jan 2017 (estimated)
- 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 objective of this study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.
Detailed description
The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially to detect cancer and disk displacement with temporomandibular disorders. The prevalence of tongue cancer may increase with ageing population. A clear MR image is indispensable for clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be prominent with the patients without the occlusal support. The objective of this pilot study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dentulous | No intervention | –MR Imaging was collected with condition at the tongue at rest position. |
| edentulous without denture wear. | No intervention | –MR Imaging was collected without denture wear. |
| edentulous with denture wear. | Experimental | Device: denture wear.MR Imaging was collected with denture wear. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- dentulous
- edentulous classified Eichner' s classfication
Key exclusion criteria (4 listed)
- involuntary motion occurs during imaging
- absolutely contraindicated or as a rule contraindicated of MRI examination
- subjects have ferromagnetic metals in the oral cavity
- subjects can not swallow naturally
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 |
|---|---|---|
| denture wear.MR Imaging was collected with or without denture wear. | Device | edentulous with denture wear. |
Primary outcome
Luminance standard deviation value on MR image
Time frame: MR Imaging was collected with each condition.Through study completion, an average of 2 year
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 11 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Yasuhiko Kawai, DDS MSc PhD study chair
Nihon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing denture wear. in people with Magnetic Resonance Imaging, run by Nihon University at 1 site in Japan.
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 2 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 11 Apr 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 Japan. 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?
Luminance standard deviation value on MR image (time frame: MR Imaging was collected with each condition.Through study completion, an average of 2 year). 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 11 Apr 2018.