UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurements of tongue movement during mastication
Title of the study (Brief title)	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	Kan Nagao
Organization	The University of Tokushima
Division name	Department of Oral & Maxillofacial Prosthodontics and Oral Implamtology
Address	3-18-15 Kuramoto, Tokushima
TEL	088-633-7347
Email	kan@tokushima-u.ac.jp

Public contact
Name of contact person	Keiko Fujimoto
Organization	The University of Tokushima
Division name	Department of Oral & Maxillofacial Prosthodontics and Oral Implamtology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 10 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022252