UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043569 |
|---|---|
| Receipt number | R000049399 |
| Scientific Title | An exploratory study to evaluate changes in hyoid bone elevation by a pulsed magnetic stimulator for patients with oral hypofunction. |
| Date of disclosure of the study information | 2021/03/10 |
| Last modified on | 2025/03/12 09:25:24 |
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Basic information
Public title
An exploratory study to evaluate changes in hyoid bone elevation by a pulsed magnetic stimulator for patients with oral hypofunction.
Acronym
An exploratory study: Evaluate changes in hyoid bone elevation by a pulsed magnetic stimulator.
Scientific Title
An exploratory study to evaluate changes in hyoid bone elevation by a pulsed magnetic stimulator for patients with oral hypofunction.
Scientific Title:Acronym
An exploratory study: Evaluate changes in hyoid bone elevation by a pulsed magnetic stimulator.
Region
| Japan |
Condition
Condition
Oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in hyoid bone elevation with pulsed magnetic stimulators.
Basic objectives2
Others
Basic objectives -Others
An exploratory study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The Amount of change in hyoid bone elevation after six week rehabilitation.
Key secondary outcomes
occlusal force, tongue pressure, masticatory function, etc
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Magnetic stimulations are undertaken once a week for 6 weeks against suprahyoid muscles.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have completed dental treatment at Tohoku University Hospital.
Persons with oral hypofunction even after dental treatment.
Those who voluntarily agreed to participate in this study.
Key exclusion criteria
Persons with dysphagia (including drug-induced dysphagia).
Persons taking drugs that promote the swallowing reflex or cough reflex.
Those who have a metal or cardiac pacemaker near the stimulation site.
Persons with a history of epilepsy or intracranial lesions.
Persons with dementia.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Naru |
| Middle name | |
| Last name | Shiraishi |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Advanced Prosthetic Dentistry
Zip code
098-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8369
keiichi.sasaki.e6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Naru |
| Middle name | |
| Last name | Shiraishi |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Advanced Prosthetic Dentistry
Zip code
098-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8369
Homepage URL
naru.shiraishi.c1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Division of Advanced Prosthetic Dentistry
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
er@rinri.hosp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049399
