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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042400
Receipt No. R000048396
Scientific Title Effect of oral texture perception on mastication and swallowing in healthy adults
Date of disclosure of the study information 2020/11/10
Last modified on 2020/11/09

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Basic information
Public title Effect of oral texture perception on mastication and swallowing in healthy adults
Acronym Effect of oral texture perception on mastication and swallowing in healthy adults
Scientific Title Effect of oral texture perception on mastication and swallowing in healthy adults
Scientific Title:Acronym Effect of oral texture perception on mastication and swallowing in healthy adults
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationships between oral texture perception and other oral function such as motor and secretory function.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correlation between acuity of texture perception and reproducibility of swallowing movement.
Key secondary outcomes The correlation between acuity of texture perception and ability to adjust masticatory movement.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit
45 years-old >
Gender Male and Female
Key inclusion criteria (1) Healthy individual between the ages 18 and 44.
(2) Individual who has provided written consent to participate in this study.
Key exclusion criteria (1) Individual with 4 or more missing teeth except for the third molars.
(2) Individual who has pain or impaired sensation of orofacial area.
(3) Individual with impaired stomatognathic motion.
(4) Individual with any disease which may cause neurological disability.
(5) Individual with allergy to instruments or foods which will be used in this study.
(6)Individual with eating or swallowing disability.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yasue
Middle name
Last name Tanaka
Organization Tohoku University Graduate School of Dentistry
Division name Division of Aging and Geriatric Dentistry
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8396
Email yasue.tanaka.b3@tohoku.ac.jp

Public contact
Name of contact person
1st name Yasue
Middle name
Last name Tanaka
Organization Tohoku University Graduate School of Dentistry
Division name Division of Aging and Geriatric Dentistry
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8396
Homepage URL
Email yasue.tanaka.b3@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Lotte Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tohoku University Graduate School Dentistry
Address 4-1, Seiryo-machi, Aoba-ku, Sendai
Tel 022-717-8244
Email den-syom@grp.tohoku.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 11 Month 10 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 05 Day
Date of IRB
2020 Year 10 Month 30 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2020 Year 11 Month 09 Day
Last modified on
2020 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048396

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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