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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019260
Receipt No. R000022252
Scientific Title Measurements of tongue movement during mastication
Date of disclosure of the study information 2015/10/07
Last modified on 2017/10/08

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Basic information
Public title Measurements of tongue movement during mastication
Acronym Measurements of tongue movement during mastication
Scientific Title Measurements of tongue movement during mastication
Scientific Title:Acronym Measurements of tongue movement during mastication
Region
Japan

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

Objectives
Narrative objectives1 To investigate the influence by bolus size and food consistency on tongue movement during mastication.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sagittal tongue movement,tongue pressure,jaw movement
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Sagittal tongue movements are recorded with video fluorography in lateral projection. For recordings, small lead discs are used as radiopaque markers to quantify the tongue surface. Also, tongue pressures are measured using a sensor sheet system (Swallow Scan, Nitta Co., Osaka, Japan) with five measurement points to predict frontal tongue shift. In addition, the jaw movement is measured using a marker-tracking system (V120: Duo, SPICE Co., Tokyo, Japan). These three devices are synchronized and tongue movement according to mastication process is observed over time.
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
100 years-old >
Gender Male and Female
Key inclusion criteria The volunteers are healthy adults
Key exclusion criteria Patient without ability to consent
Patient without dysphasia
Person who is determined to be unable to make the secure measured by measure
Person who during pregnancy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kan Nagao
Organization The University of Tokushima
Division name Department of Oral & Maxillofacial Prosthodontics and Oral Implamtology
Zip code
Address 3-18-15 Kuramoto, Tokushima
TEL 088-633-7347
Email kan@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Fujimoto
Organization The University of Tokushima
Division name Department of Oral & Maxillofacial Prosthodontics and Oral Implamtology
Zip code
Address 3-18-15 Kuramoto, Tokushima
TEL 088-633-7347
Homepage URL
Email c301451014@tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima
Institute
Department

Funding Source
Organization The University of Tokushima
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
Address
Tel
Email

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
2015 Year 10 Month 07 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
2015 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 07 Day
Last modified on
2017 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022252

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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