UMIN-CTR Clinical Trial

Basic information
Public title	Survey on oral function management methods according to the degree of cognitive decline
Acronym	Survey on oral function management methods according to the degree of cognitive decline
Scientific Title	Survey on oral function management methods according to the degree of cognitive decline
Scientific Title:Acronym	Survey on oral function management methods according to the degree of cognitive decline
Region	Japan

Condition
Condition	dementia
Classification by specialty	Neurology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	With the aging of the population, the rapid increase of dementia patients has become a social issue in Japan. The condition of dementia changes depending on its type and stage (stage). To investigate the method of dental treatment for patients with dementia at each stage, and clarify the appropriate oral management method at each stage.
Basic objectives2	Others
Basic objectives -Others	To investigate the method of swallowing rehabilitation for patients with dementia at each stage, and clarify the appropriate oral management method at each stage.
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MMSE, HDS-R DMFT, PCR, FOIS
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	60 years-old <=
Age-upper limit	120 years-old >
Gender	Male and Female
Key inclusion criteria	Elderly patients with dementia who received visiting medical treatment
Key exclusion criteria	Not covered by treatment
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takatoshi Middle name Last name Iida
Organization	Kanagawa Dental University
Division name	Division of Medically Compromised Geriatric Dentistry
Zip code	238-8570
Address	yokosuka city ogawa chou 1-23
TEL	0468228874
Email	takatoshii0330@gmail.com

Public contact
Name of contact person	1st name Takatoshi Middle name Last name Iida
Organization	Kanagawa Dental University
Division name	Division of Medically Compromised Geriatric Dentistry
Zip code	238-8570
Address	yokosuka city ogawa chou 1-23
TEL	0468228874
Homepage URL
Email	takatoshii0330@gmail.com

Sponsor
Institute	Kanagawa Dental University Division of Medically Compromised Geriatric Dentistry
Institute
Department

Funding Source
Organization	Kanagawa Dental University Division of Medically Compromised Geriatric Dentistry
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanagawa Dental University
Address	yokosuka city ogawa chou 1-23
Tel	0468228874
Email	takatoshii0330@gmail.com

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	2020 Year 06 Month 24 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	2019 Year 02 Month 20 Day
Date of IRB	2019 Year 02 Month 20 Day
Anticipated trial start date	2020 Year 06 Month 28 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	There is a preliminary test

Management information
Registered date	2020 Year 06 Month 23 Day
Last modified on	2020 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046672