UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025988 |
|---|---|
| Receipt number | R000028745 |
| Scientific Title | Retrospective multi-institutional joint study on masticatory ability |
| Date of disclosure of the study information | 2017/02/10 |
| Last modified on | 2020/02/06 14:45:01 |
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Basic information
Public title
Retrospective multi-institutional joint study on masticatory ability
Acronym
Retrospective multi-institutional joint study on masticatory ability
Scientific Title
Retrospective multi-institutional joint study on masticatory ability
Scientific Title:Acronym
Retrospective multi-institutional joint study on masticatory ability
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dysphagia could often be observed in elderly population. Considering the achievement of daily nutrition, objective evaluation of masticatory function would be of importance. Distinguishing the foodstuffs which could be fully masticated would be an important information on improving QoL of the elderly.
This study aimed to evaluate digital images of food particles in masticated bolus, which were already taken in our university or other cooperating universities, to establish the data to support the availability of our masticatory efficiency evaluation system.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
masticatory efficiency indexes (HI and SI)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Data which were already collected in cooperative institutes
Key exclusion criteria
none
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Minagi |
Organization
Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL
086-235-6685
minagi@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Minagi |
Organization
Okayama University
Division name
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL
086-235-6685
Homepage URL
minagi@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 02 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collect the digital images of food particles and analyze them.
Management information
Registered date
| 2017 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028745
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
