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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043569
Receipt No. 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 2021/10/12

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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 Keiichi
Middle name
Last name Sasaki
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
Email 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
Email naru.shiraishi.c1@tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Dentistry
Division of Advanced Prosthetic Dentistry
Institute
Department

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
Email 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
2023 Year 09 Month 30 Day
Date of closure to data entry
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
2021 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049399

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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