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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033696
Receipt No. R000038419
Official scientific title of the study The effect of tongue cleaning on the pharyngeal circumference and the body
Date of disclosure of the study information 2018/08/09
Last modified on 2018/08/09

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Basic information
Official scientific title of the study The effect of tongue cleaning on the pharyngeal circumference and the body
Title of the study (Brief title) The effect of tongue cleaning on the pharyngeal circumference and the body
Region
Japan

Condition
Condition aspiration pneumonitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The goal of this study is to clarify the effect of tongue cleaning on peripharyngeal muscle.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of peripharyngeal muscle 6 weeks after starting tongue cleaning
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention group is implemented daily oral care with tongue cleaning for 3 months to 1 year.
Interventions/Control_2 Control group is implemented daily oral care alone for 3 months to 1 year.
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 Residents in for the elderly with agreement to this study.
Key exclusion criteria Residents with refusal of this study, or with difficulty in communicating.
Target sample size 30

Research contact person
Name of lead principal investigator Maya Izumi
Organization Kyushu Dental University
Division name Faculty of Dentistry
Address 2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL +81-93-285-3102
Email r15izumi@fa.kyu-dent.ac.jp

Public contact
Name of contact person Maya Izumi
Organization Kyushu Dental University
Division name Faculty of Dentistry
Address 2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL +81-93-285-3102
Homepage URL
Email r15izumi@fa.kyu-dent.ac.jp

Sponsor
Institute Kyushu Dental University
Institute
Department

Funding Source
Organization Kyushu Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

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
2018 Year 08 Month 09 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 09 Day
Anticipated trial start date
2021 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 09 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038419

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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