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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035596
Receipt No. R000040559
Scientific Title The study of the effective tongue movement methods as functional oral rehabilitation
Date of disclosure of the study information 2019/01/20
Last modified on 2019/07/25

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Basic information
Public title The study of the effective tongue movement methods as functional oral rehabilitation
Acronym The study of the functional oral rehabilitation by tongue movement
Scientific Title The study of the effective tongue movement methods as functional oral rehabilitation
Scientific Title:Acronym The study of the functional oral rehabilitation by tongue movement
Region
Japan

Condition
Condition Oral hypofunction
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine whether some kinds of tongue movements are effective for improving the oral hypofunction among the elderly people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes tongue pressure
Key secondary outcomes Dry mouth condition
Speaking function
Lips pressure
etc

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 YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The group 1 is to do tongue exercise which the tongue tip push up the palatal lid direction 5 times. Intervention is performed twice a day.
Interventions/Control_2 The group 2 is to do tongue exercise which the tongue tip touch the behind of lips and turn around right and left each 5 times. Intervention is performed twice a day.
Interventions/Control_3 The group 3 is to do tongue exercise which the tongue tip touch the right and left buccal mucosa and turn around each 5 times. Intervention is performed twice a day.
Interventions/Control_4 Control group is not given any instructs.

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 1)Dental outpatients
2)Oral hypofunction
Key exclusion criteria 1)The elderly who staying in nursing homes or hospitals
2)Having oral cancer,
3)Received intraoral radiation therapy at any time in the past
4)Having salivary gland disease.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Mami
Middle name
Last name Endoh
Organization Nihon university dentistry at Matsudo
Division name Department of special needs dentistry
Zip code 271-8587
Address 2-870-1, Sakae cho- nishi, Matsudo City, Chiba prefecture, Japan
TEL 09030428130
Email endoh.mami@nihon-u.ac.jp

Public contact
Name of contact person
1st name Mami
Middle name
Last name Endoh
Organization Nihon university dentistry at Matsudo
Division name Department of special needs dentistry
Zip code 271-8587
Address 2-870-1, Sakae cho- nishi, Matsudo City, Chiba prefecture, Japan
TEL 09030428130
Homepage URL
Email endoh.mami@nihon-u.ac.jp

Sponsor
Institute Nihon university dentistry at Matsudo, Department of special needs dentistry
Institute
Department

Funding Source
Organization Nihon university dentistry at Matsudo, Department of special needs dentistry
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Nihon University School of Dentistry at Matsudo
Address 2-870-1, Sakae cho- nishi, Matsudo City, Chiba prefecture, Japan
Tel 0473609274
Email endoh.mami@nihon-u.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 朝田歯科医院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 20 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
2018 Year 10 Month 10 Day
Date of IRB
2019 Year 02 Month 28 Day
Anticipated trial start date
2019 Year 01 Month 27 Day
Last follow-up date
2024 Year 02 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 19 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040559

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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