UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044615 |
|---|---|
| Receipt number | R000050965 |
| Scientific Title | A study on the effect of an oral appliance to enhance tongue force |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2024/01/16 20:10:26 |
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Basic information
Public title
Tongue training with a mouthpiece
Acronym
Tongue training with a mouthpiece
Scientific Title
A study on the effect of an oral appliance to enhance tongue force
Scientific Title:Acronym
A study on the effect of an oral appliance to enhance tongue force
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if the use of the oral appliance can improve tongue force and ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
tongue pressure
Key secondary outcomes
oral diadochokinesis, jaw-opening force, masticatory performance, the quality of tongue and geniohyoid muscle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wear the oral appliance with thickness for a month and try dry swallow.
Interventions/Control_2
Wear the normal oral appliance for a month and try dry swallow.
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 agree to participate in this study.
Those 65-year-old or older.
Those who have already finished caries, endodontic, periodontic, and prothodontic treatment.
Those whose activities of daily living is dependent.
Key exclusion criteria
Those who cannot obey to the instruction.
Those who have organic diseases which can cause dysphagia.
Those who have progressive neuromuscular diseases.
Those who have severe temporomandibular disorder.
Those who have tooth mobility.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Division name
Department of Dysphagia Rehabilitation
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-Ward, Tokyo
TEL
03-5803-5561
harukatohara@hotmail.com
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Division name
Department of Dysphagia Rehabilitation
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-Ward, Tokyo
TEL
03-5803-5561
Homepage URL
harukatohara@hotmail.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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
0358035776
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
| 2021 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | 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 | 06 | Month | 22 | 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=R000050965
