UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044947 |
|---|---|
| Receipt number | R000045236 |
| Scientific Title | Changes of chewing ability to gradual bite force load using confectionery |
| Date of disclosure of the study information | 2021/07/24 |
| Last modified on | 2022/02/04 12:47:30 |
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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
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
nishizaki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045236
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