UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047712 |
|---|---|
| Receipt number | R000054401 |
| Scientific Title | Crossover study on the effects of palate coverage on taste and oral texture sensation in healthy adults |
| Date of disclosure of the study information | 2022/05/10 |
| Last modified on | 2022/05/10 21:57:47 |
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Basic information
Public title
Crossover study on the effects of palate coverage on taste and oral texture sensation in healthy adults
Acronym
Effect of palatal coverage on oral sensation
Scientific Title
Crossover study on the effects of palate coverage on taste and oral texture sensation in healthy adults
Scientific Title:Acronym
Effect of palatal coverage on oral sensation
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify changes in taste and oral texture sensation that occur when the palate is covered with palatal plate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Discrimination threshold for aqueous xanthan gum solutions
Key secondary outcomes
Discrimination threshold for microcrystalline cellulose aqueous suspension
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
With palatal plate -> Without palatal plate
Interventions/Control_2
Without palatal plate -> With palatal plate
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Consent of the individual to participate in this study
Key exclusion criteria
Pain, sensory disturbance, or motor abnormality in the temporomandibular region
Undergoing orthodontic treatment
Experience of wearing dentures covering the palate
Abnormal gag reflex
Eating and swallowing disorders
Allergy to equipment or food used in the research
Inappropriateness as a research participant as determined by the researcher
Target sample size
20
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
022-717-8396
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
022-717-8396
Homepage URL
yasue.tanaka.b3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
Tel
0227178244
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 | 05 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054401
| 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 |
