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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020293
Receipt No. R000023430
Scientific Title Study on oral health status among community dwelling people with special needs.
Date of disclosure of the study information 2016/01/15
Last modified on 2015/12/21

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Basic information
Public title Study on oral health status among community dwelling people with special needs.
Acronym Oral health status among people with special needs.
Scientific Title Study on oral health status among community dwelling people with special needs.
Scientific Title:Acronym Oral health status among people with special needs.
Region
Japan

Condition
Condition Oral health status among community dwelling people with special needs.
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims are to give oral health education to people who work at an employment support office and to consider a future oral health promotion plan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation by result of oral examination and questionnaire.
Key secondary outcomes

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Base-line oral cavity examination.
Oral health education once a month for three months.
Oral cavity examination after 3 months.
Oral cavity examination after 6 months.
Interventions/Control_2 Base-line oral cavity examination.
Oral cavity examination after 3 months.
Oral health education once a month for three months.
Oral cavity examination after 6 months.
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

Not applicable
Gender Male and Female
Key inclusion criteria Person who works at employment support office for people with special needs.
Key exclusion criteria Under 18 year-old
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Kawaguchi
Organization Tokyo Medical and Dental University
Division name Oral health promotion
Zip code
Address 1-5-45, Yushima, bunkyo-ku, Tokyo, Japan
TEL 03-5803-5476
Email yoko.ohp@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsue Kamisawa
Organization Tokyo Medical and Dental University
Division name Oral health promotion
Zip code
Address 1-5-45 Yushima, bunkyo-ku, Tokyo, Japan
TEL 03-5803-5476
Homepage URL
Email ma150024@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 01 Month 15 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
2015 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 02 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
2015 Year 12 Month 21 Day
Last modified on
2015 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023430

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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