UMIN-CTR Clinical Trial

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
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	0227178396
Homepage URL
Email	yasue.tanaka.b3@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
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 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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054924