UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050652 |
|---|---|
| Receipt number | R000057585 |
| Scientific Title | Investigative research on masticatory strength and eating habits for all generations |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/04/02 08:21:50 |
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Basic information
Public title
Investigative research on masticatory strength and eating habits for all generations
Acronym
Investigative research on masticatory strength and eating habits for all generations
Scientific Title
Investigative research on masticatory strength and eating habits for all generations
Scientific Title:Acronym
Investigative research on masticatory strength and eating habits for all generations
Region
| Japan |
Condition
Condition
Oral hypofunction
Oral Dysfunctional Developmental Dysfunctions
Classification by specialty
| Dental medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the masticatory strength of healthy men and women of all generations.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between masticatory strength and eating habits.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bite force, chewing ability, eating habits, gum style, grip strength, length, weight
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Clenching of the pressure-sensitive sheet at the occlusal fit position for 3 seconds.
The sensor site of the oral function monitor is inserted into the mouth for clenching.
Chew the color-changing gum for chewing ability test 60 times at the pace of once a second.
The balloon of the tongue depressometer is crushed between the tongue and the anterior part of the palate with maximum force for several seconds.
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
| 5 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women aged 5-89
Key exclusion criteria
Those who have difficulty in chewing chewing gum, such as temporomandibular joint disorder or food allergy.
Those who have problems with cognitive function.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Graduate School of Medical amd Dental Siences, Tokyo Medical and Dental University
Division name
Degital Dentistry
Zip code
113-8649
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5379
m.kanazawa.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Degital Dentistry
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5379
Homepage URL
m.kanazawa.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5379
m.kanazawa.gerd@tmd.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
| 2023 | Year | 05 | Month | 01 | 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
878
Results
We were able to assess differences in masticatory performance, eating habits, and associated factors in multigenerational study participants. Analysis is currently underway.
Results date posted
| 2024 | Year | 04 | Month | 02 | Day |
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
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 14 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057585
