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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040047
Receipt No. R000045658
Scientific Title An epidemiological study in the association of oral condition with disability in patients with home-visit dental treatment
Date of disclosure of the study information 2020/07/01
Last modified on 2020/04/03

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Basic information
Public title An epidemiological study in the association of oral condition with disability in patients with home-visit dental treatment
Acronym An epidemiological study in the association of oral condition with disability in patients with home-visit dental treatment
Scientific Title An epidemiological study in the association of oral condition with disability in patients with home-visit dental treatment
Scientific Title:Acronym An epidemiological study in the association of oral condition with disability in patients with home-visit dental treatment
Region
Japan

Condition
Condition Oral candidiasis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine factors that are related to an oral health condition and functional disability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral candidiasis, Nutritional status, and Activities of Daily Living
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 70 years or older
Receipt of long-term care insurance
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Takamasa
Middle name
Last name Komiyama
Organization Tohoku University Graduate School of Dentistry
Division name Aging and Geriatric Dentistry
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba-ku, Sendai-city, Miyagi, Japan
TEL 0227178396
Email takamasa.komiyama.c6@tohoku.ac.jp

Public contact
Name of contact person
1st name Takamasa
Middle name
Last name Komiyama
Organization Tohoku University Graduate School of Dentistry
Division name Aging and Geriatric Dentistry
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba-ku, Sendai-city, Miyagi, Japan
TEL 0227178396
Homepage URL
Email takamasa.komiyama.c6@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 Tohoku University Graduate School of Dentistry
Address 4-1, Seiryo-machi, Aoba-ku, Sendai-city, Miyagi, Japan
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
2020 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
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 04 Month 03 Day
Last modified on
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045658

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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