UMIN-CTR Clinical Trial

Basic information
Public title	Changes of chewing ability to gradual bite force load using confectionery
Acronym	Changes of chewing ability to gradual bite force load using confectionery
Scientific Title	Changes of chewing ability to gradual bite force load using confectionery
Scientific Title:Acronym	Changes of chewing ability to gradual bite force load using confectionery
Region	Japan

Condition
Condition	dysphagia, oral hypofunction
Classification by specialty	Rehabilitation medicine Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In Japan, elderly patients with dysphagia are increasing with the aging. In the past, the treatment of dysphagia was "how to reduce the difficulty of food intake", but in recent years, the transition from liquid food to solid food has been atracting attention, such as mastication training.This time, the evaluation focuses on the occlusal force.The physical properties of food include "hardness", "adhesiveness", and "cohesiveness". In this study, we created food scales focusing on "hardness" and "occlusal force". Understand the power and see the change in masticatory function while expecting an increase in occlusal force just by taking it in stages.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Chewing ability
Key secondary outcomes	Tongue pressure test, bite force test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	The participants in intervention group were allowed to eat confectionery for one week. After a week, they were examined changes in occlusal force, tongue pressure, masticatory efficiency.
Interventions/Control_2	The participants in non-intervention group were not allowed to eat confectionery. After a week, they were examined changes in occlusal force, tongue pressure, masticatory efficiency.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients over 65 years old who could communicate, but have oral hypofunction and dysphagia severity scale (DSS) 3 (water aspiration or higher).
Key exclusion criteria	food allergy, and cognitive decline
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Takatoshi Middle name Last name Iida
Organization	Kanagawa Dental University (present affiliation: Health Sciences University of Hokkaido)
Division name	Department of Geriatric Dentistry
Zip code	238-8580
Address	82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL	046-845-3168
Email	nishizaki@kdu.ac.jp

Public contact
Name of contact person	1st name Hitomi Middle name Last name Nishizaki
Organization	Kanagawa Dental University
Division name	Department of Geriatric Dentistry
Zip code	238-8580
Address	82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL	046-845-3168
Homepage URL
Email	nishizaki@kdu.ac.jp

Sponsor
Institute	Kanagawa Dental University
Institute
Department

Funding Source
Organization	Kanagawa Dental University
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	Kanagawa Dental University
Address	82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
Tel	046-845-3168
Email	morimoto@kdu.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	神奈川歯科大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 24 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	Enrolling by invitation
Date of protocol fixation	2021 Year 07 Month 24 Day
Date of IRB	2020 Year 03 Month 02 Day
Anticipated trial start date	2021 Year 07 Month 24 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 06 Month 30 Day
Date trial data considered complete	2023 Year 09 Month 30 Day
Date analysis concluded	2023 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 07 Month 24 Day
Last modified on	2022 Year 02 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045236