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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024933
Receipt No. R000028685
Scientific Title Effects dementia and the oral health of dementia patients by dentists and dental hygienists at residences in group home
Date of disclosure of the study information 2016/11/21
Last modified on 2017/02/01

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Basic information
Public title Effects dementia and the oral health of dementia patients by dentists and dental hygienists at residences in group home
Acronym Effects dementia and the oral health of dementia patients
Scientific Title Effects dementia and the oral health of dementia patients by dentists and dental hygienists at residences in group home
Scientific Title:Acronym Effects dementia and the oral health of dementia patients
Region
Japan

Condition
Condition Dementia
Classification by specialty
Neurology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The assessment of effects dementia and the oral health of dementia patients by dentists and dental hygienists at residences in group home
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Conditions of the number of remain teeth and denture
2. long-term care classification
3. Assessment oral function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Dentists and dental hygienists assess the oral condition once a week
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Dementia patients at residences in group home
Key exclusion criteria Assessed as inappropriate for this test by the doctor responsible for the test
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Shinsei-kai, Medical Association, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 21 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 Completed
Date of protocol fixation
2007 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 21 Day
Last modified on
2017 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028685

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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