UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056971 |
|---|---|
| Receipt number | R000063013 |
| Scientific Title | Analysis of the Effects of Oral Rehabilitation Based on Neuroplastic Changes |
| Date of disclosure of the study information | 2025/02/07 |
| Last modified on | 2025/02/07 14:43:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of the Effects of Oral Rehabilitation Based on Neuroplastic Changes
Acronym
Analysis of the Effects of Oral Rehabilitation
Scientific Title
Analysis of the Effects of Oral Rehabilitation Based on Neuroplastic Changes
Scientific Title:Acronym
Analysis of the Effects of Oral Rehabilitation
Region
| Japan |
Condition
Condition
oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to comprehensively analyze the neuroplasticity parameters, such as the amplitude of Motor Evoked Potentials (MEP) in response to Transcranial Magnetic Stimulation (TMS), and oral function parameters, such as tongue pressure, before and after muscle function training intervention. This analysis will evaluate the effectiveness and sustainability of muscle function training in the orofacial region.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
central parameters: Tongue pressure, Oral diadochokinesis, Lip closure strength, Occlusal force, Repetitive swallowing test, Muscle activity
peripheral parameters: Motor Evoked Potentials (MEPs) induced by TMS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Performing oral rehabilitation at home
Interventions/Control_2
Do not perform oral rehabilitation at home
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person with low tongue pressure
Key exclusion criteria
people who are objectively deemed incapable of giving informed consent
people with organic or functional tongue or lip disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Shimada |
Organization
Osaka Dental University
Division name
Department of Oral Health Sciences Faculty of Health Sciences
Zip code
5731144
Address
1-4-4 Makinohonmachi, Hirakata, Osaka 573-1144 Japan
TEL
0728569953
shimada-a@cc.osaka-dent.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Shimada |
Organization
Osaka Dental University
Division name
Department of Oral Health Sciences Faculty of Health Sciences
Zip code
5731144
Address
1-4-4 Makinohonmachi, Hirakata, Osaka 573-1144 Japan
TEL
0728569953
Homepage URL
shimada-a@cc.osaka-dent.ac.jp
Sponsor or person
Institute
Osaka Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
The ethics committee of Osaka Dental University
Address
8-1, Kashiwa Hanazonocho, Hirakata, Osaka, Japan, 573-1121
Tel
072-864-3111
oduresearch@cc.osaka-dent.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 07 | 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
| 2023 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063013
