UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054849 |
|---|---|
| Receipt number | R000062670 |
| Scientific Title | Research on the number of chews for one bite and small bite in older adults. |
| Date of disclosure of the study information | 2024/07/02 |
| Last modified on | 2024/09/24 21:12:54 |
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Basic information
Public title
Research on the number of chews for one bite and small bite in older adults.
Acronym
Research on the number of chews for one bite and small bite in older adults.
Scientific Title
Research on the number of chews for one bite and small bite in older adults.
Scientific Title:Acronym
Research on the number of chews for one bite and small bite in older adults.
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research the difference between the counts for a mouthful of chewing and the number of times required for a small mouthful in adults aged 60 and over who are eating regular foods.
Basic objectives2
Others
Basic objectives -Others
Research factors related to salivary bacterial counts.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, sex, number of remaining teeth, oral diadochokinesis, OHI-DI, saliva flow rate, number of chews per mouthful, number of chews per slightly less than mouthful, number of bacteria in saliva (bacterial culture)
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
The participants were given a bite of food to chew. Next, they were given a small bite to chew.
The intervention was only performed once at the time of measurement.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Regular intake of food
Key exclusion criteria
Unable to obtain consent
Complaints of pain in teeth or mouth
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Department of Oral Health, Faculty of Dentistry
Division name
Department of Oral Health, Faculty of Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL
093-285-3109
r17funahara@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyusyu Dental University
Division name
Department of Oral Health, Faculty of Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL
093-285-3109
Homepage URL
r17funahara@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Self-Procurement
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 Review Committee, Kyushu Dental University
Address
2-6-1, Manazuru, Kitakyushu, Japan
Tel
093-285-3011
kyoumu@kyu-dent.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
| 2024 | Year | 07 | Month | 02 | 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
| 2024 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062670
