UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048195 |
|---|---|
| Receipt number | R000054924 |
| Scientific Title | Relationship between oral texture perception and oral hypofunction in healthy older adults |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/06/29 17:57:22 |
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Basic information
Public title
Relationship between oral texture perception and oral hypofunction in healthy older adults
Acronym
Relationship between oral texture perception and oral hypofunction in healthy older adults
Scientific Title
Relationship between oral texture perception and oral hypofunction in healthy older adults
Scientific Title:Acronym
Relationship between oral texture perception and oral hypofunction in healthy older adults
Region
| Japan |
Condition
Condition
Oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between oral texture sensation and oral hypofunction.
Basic objectives2
Others
Basic objectives -Others
correlation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discrimination threshold of xanthan gum aqueous solution
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Health individual over 65 years old
(2) Individual who has provided written consent to participate in this study
Key exclusion criteria
(1)Individual suffering from diseases of the brain and nervous system
(2)Individual who do not have prosthetic treatment for missing permanent teeth other than third molars.
(3)Individual with removable dentures
(4) Patients with pain, sensory abnormality, or motor abnormality in the maxillofacial region.
(5) Individual with allergy to instruments or materials used in the experiments.
(6) Smokers
(7) Individual with feeding and swallowing difficulties
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasue |
| Middle name | |
| Last name | Tanaka |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Aging and Geriatric Dentistry
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227178396
yasue.tanaka.b3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasue |
| Middle name | |
| Last name | Tanaka |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Aging and Geriatric Dentistry
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227178396
Homepage URL
yasue.tanaka.b3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Lotte Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Dentis
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-8244
den-syom@grp.tohoku.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
| 2022 | Year | 07 | 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
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2022 | Year | 06 | Month | 29 | Day |
Last modified on
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054924
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
