UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018894 |
|---|---|
| Receipt number | R000021860 |
| Scientific Title | The effects of oral health promotion on Lifestyle-related diseases |
| Date of disclosure of the study information | 2015/09/02 |
| Last modified on | 2019/03/06 09:27:56 |
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Basic information
Public title
The effects of oral health promotion on Lifestyle-related diseases
Acronym
The effects of oral health promotion on Lifestyle-related diseases
Scientific Title
The effects of oral health promotion on Lifestyle-related diseases
Scientific Title:Acronym
The effects of oral health promotion on Lifestyle-related diseases
Region
| Japan |
Condition
Condition
lifestyle-related disease
Classification by specialty
| Medicine in general | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is conducted the effects of oral health promotion on lifestuyle-related diseases such as diabetes condition and aceton of mouth air.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c check baseline and 1,3,6M after oral health care promotion
Key secondary outcomes
oral malodor(VSC,Aceton), periodontal tissue condition, blood glucose level, etc. check baseline and 1,3,6M after oral health care promotion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
oral health care promotion are carried out at first, 1, 3M visits and check at first, 1, 3, 6M visits.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with lifestyle-related diseases such as diabetes
Key exclusion criteria
patients with infection diseases and serious condition
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinada Kayoko |
Organization
Tokyo Medical and Dental University, graduate school
Division name
preventive oral health care science
Zip code
Address
1-5-45Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4096
shinada.ohp@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinada Kayoko |
Organization
Tokyo Medical and Dental University, graduate school
Division name
preventive oral health care science
Zip code
Address
1-5-45Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4096
Homepage URL
shinada.ohp@tmd.ac.jp
Sponsor or person
Institute
Preventive oral health care science, Tokyo Medical and Dental University, graduate school
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
東京医科歯科大学医学部付属病院（東京都）、東京医科歯科大学歯学部口腔保健学科研究室および実習室（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2015 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 02 | Day |
Last modified on
| 2019 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021860
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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