UMIN-CTR Clinical Trial

Basic information
Public title	Effects of food physical properties and aging on chewing and swallowing functions
Acronym	Effects of food physical properties and aging on chewing and swallowing functions
Scientific Title	Effects of food physical properties and aging on chewing and swallowing functions
Scientific Title:Acronym	Effects of food physical properties and aging on chewing and swallowing functions
Region	Japan

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

Objectives
Narrative objectives1	Clarify the effects of food physical properties and aging on chewing and swallowing functions
Basic objectives2	Others
Basic objectives -Others	Derivation of muscle activity using electromyography
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Derivation of muscle activity
Key secondary outcomes

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	80 years-old >=
Gender	Male
Key inclusion criteria	(1)Male (2)Normal toothed jaw (no missing teeth and functional abnormalities in the oral and maxillofacial system) (3)Age 18-34 years or 70-80 years (at the time of enrollment) (4)Persons who have given their written consent to participate in the study
Key exclusion criteria	(1)Female (2)Under 18 years old, 35-69 years old, over 81 years old (3)Those with oral hypofunction (4)Those with dysphagia
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Ogawa
Organization	Tohoku University
Division name	Graduate School of Dentistry Division of Advanced Prosthetic Dentistry
Zip code	980-8575
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Miyagi
TEL	022-717-8369
Email	toru.ogawa.d7@tohoku.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Ogawa
Organization	Tohoku University
Division name	Graduate School of Dentistry Division of Advanced Prosthetic Dentistry
Zip code	980-8575
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Miyagi
TEL	022-717-8369
Homepage URL
Email	toru.ogawa.d7@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	None
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	Ethics Committee of Tohoku University Graduate School of Dentistry
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Miyagi
Tel	022-728-4205
Email	Ec-den@rinri.hosp.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	2022 Year 09 Month 30 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	2022 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 30 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Although there have been many studies on food mass formation by mastication, there have been few studies on the relationship between the physical properties of the food mass immediately before swallowing and further electromyographic evaluation. Since the physical properties of a food mass just before swallowing may have a significant impact on the ease of swallowing, it is important to clarify the relationship between the physical properties of a food mass and the aspects of muscle activity of the muscles related to mastication and swallowing.

Management information
Registered date	2022 Year 09 Month 26 Day
Last modified on	2022 Year 09 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055810