UMIN-CTR Clinical Trial

Basic information
Public title	Electromyographic study on relationship between food texture and jaw and tongue muscle activity
Acronym	Electromyographic study on relationship between food texture and jaw and tongue muscle activity
Scientific Title	Electromyographic study on relationship between food texture and jaw and tongue muscle activity
Scientific Title:Acronym	Electromyographic study on relationship between food texture and jaw and tongue muscle activity
Region	Japan

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

Objectives
Narrative objectives1	This study aimed to examine the influence of dry, crumbling food texture on the duration of the suprahyoid muscle activity during swallowing.
Basic objectives2	Others
Basic objectives -Others	This study aimed to examine the influence of food texture on the electromyographic activity of the jaw and tongue muscles during mastication and swallowing.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Duration of suprahyoid muscles activity during swallowing
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Three times of mastication and swallowing of lower dry, crumbling food texture
Interventions/Control_2	Three times of mastication and swallowing of higher dry, crumbling food texture
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	40 years-old >
Gender	Male and Female
Key inclusion criteria	20 years old <=
Key exclusion criteria	20 years old > Eating and swallowing dysphagia Less than 28 remaining teeth Taste disorder
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Soshi Middle name Last name Hanawa
Organization	Tohoku University Graduate School of Dentistry
Division name	Advanced prosthetic dentistry
Zip code	9808575
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	0227178369
Email	s-hanawa@umin.ac.jp

Public contact
Name of contact person	1st name Soshi Middle name Last name Hanawa
Organization	Tohoku University Graduate School of Dentistry
Division name	Advanced prosthetic dentistry
Zip code	980-8575
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	0227178369
Homepage URL
Email	s-hanawa@umin.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Self funding
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	Tohoku University Graduate School of Dentistry
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel	022-717-8369
Email	s-hanawa@umin.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	2017 Year 02 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/sgf/23/2/23_96/_article/-char/ja/
Number of participants that the trial has enrolled	8
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	2017 Year 02 Month 13 Day
Date of IRB	2017 Year 10 Month 02 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 27 Day
Last modified on	2020 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030225