UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040253 |
|---|---|
| Receipt number | R000045897 |
| Scientific Title | The research on improvement of tongue movement using oral appliance |
| Date of disclosure of the study information | 2020/04/27 |
| Last modified on | 2024/01/16 20:09:47 |
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Basic information
Public title
The research on improvement of tongue movement using oral appliance
Acronym
The research on improvement of tongue movement using oral appliance
Scientific Title
The research on improvement of tongue movement using oral appliance
Scientific Title:Acronym
The research on improvement of tongue movement using oral appliance
Region
| Japan |
Condition
Condition
Swallowing disorder
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of swallowing function by the oral appliance for low tongue rest position.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tong pressure, Oral diadokokinesis, Repetitive saliva swallowing test, Modified water swallowing test, Food test, Cough test, Penetration aspiration scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To apply the oral appliance for treatment
Interventions/Control_2
To apply the oral appliance without treatment effect
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Male and female aged over 65 who take dysphagia rehabilitation treatment at Dental Hospital, nursing home, welfare facility, or patient's home.
Key exclusion criteria
Those who have poor general condition, disturbance of unconsciousness, dementia, bulbar paralysis, or experience of temporomandibular joint disorder, asthma, any disease causing swallowing disorder which is progressive or not stable, or oropharyngeal surgery caused swallowing disorder.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Hara |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Dysphagia Rehabilitation
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-Ward, Tokyo
TEL
03-5803-5562
koji19831031@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hara |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Dysphagia Rehabilitation
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-Ward, Tokyo
TEL
03-5803-5562
Homepage URL
koji19831031@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tongue Lab
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-Ward, Tokyo
Tel
03-5803-4085
info.bec@tmd.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
| 2020 | Year | 04 | Month | 27 | 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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are to carry out a pilot study before this research.
This pilot research will be a single-arm study with only the intervention group.
And the dentist who measures the outcomes will be blinded.
The participants will be adults with dysphagia.
The outcomes before and after the intervention will be compared.
Management information
Registered date
| 2020 | Year | 04 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045897
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
