UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020293 |
|---|---|
| Receipt number | 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 16:36:41 |
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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
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
ma150024@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
