UMIN-CTR Clinical Trial

Basic information
Public title	Impacts of food property and oral wetness on food residue after swallowing
Acronym	Impacts of food property and oral wetness on food residue
Scientific Title	Impacts of food property and oral wetness on food residue after swallowing
Scientific Title:Acronym	Impacts of food property and oral wetness on food residue
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal impacts of food property and oral wetness on food residue in the oral cavity after swallowing
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of food residue in the oral cavity after swallowing
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food Other
Interventions/Control_1	Eat rice, rice porridge, and pudding under two conditions; normal wetness and dry wetness oral condition
Interventions/Control_2
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	20 years-old <=
Age-upper limit	30 years-old >
Gender	Female
Key inclusion criteria	Healthy volunteer
Key exclusion criteria	Under orthodontic treatment, declined masticatory function due to missing teeth
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Junichi Middle name Last name Furuya
Organization	Graduate School, Tokyo Medical and Dental University
Division name	Department of Oral Health Care Sciences for Community and Welfare
Zip code	1670043
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-3813-6111
Email	furuya.ohcw@tmd.ac.jp

Public contact
Name of contact person	1st name Junichi Middle name Last name Furuya
Organization	Graduate School, Tokyo Medical and Dental University
Division name	Department of Oral Health Care Sciences for Community and Welfare
Zip code	1670043
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-3813-6111
Homepage URL
Email	furuya.ohcw@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel	03-3813-6111
Email	furuya.ohcw@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	2016 Year 07 Month 28 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	30
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	2016 Year 07 Month 28 Day
Date of IRB	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 01 Month 30 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 07 Month 28 Day
Last modified on	2020 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026943