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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047712
Receipt No. 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

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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
Email 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
Email yasue.tanaka.b3@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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
URL(English) 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
Registered date File name


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