UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020898 |
|---|---|
| Receipt number | R000024110 |
| Scientific Title | Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center |
| Date of disclosure of the study information | 2016/02/05 |
| Last modified on | 2016/04/04 13:00:55 |
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Basic information
Public title
Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center
Acronym
Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center
Scientific Title
Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center
Scientific Title:Acronym
Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center
Region
| Japan |
Condition
Condition
oral diseases
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This aim of this study is to examine the way of intervention of dental hygienists to make disabled persons improve their oral health by themselves.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before and after the intervation for the staffs, the oral condition of the users will be compared with the check seats.
1. The number of bacteria in the saliva and the tongue coating will be counted by using Bacterial counter.
2. The quantity of the tongue coating, the number of the remaining teeth and the functional teeth will be investigated.
3. The plaque and calculus will be analyzed with Simplified Oral Hygiene Index (OHI-S).
4. The oral moisture will be evaluated with the Moisture checker.
5. The halitosis (the concentration of VSCs) will be investigated with the Halitosis meter.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Oral health education to all staff (about 1 hour; one time)
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
People with disabilities
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi ARAKAWA |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences / Lifetime Oral Health Care Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL
03-5803-4968
shinperi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayo YASUDA |
Organization
Tokyo Medical and Dental University
Division name
Dental Hospital / Clinic for Oral Health Care
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL
03-5803-4970
Homepage URL
yasuda.ocsh@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 02 | Month | 05 | 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
| 2016 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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 | 02 | Month | 05 | Day |
Last modified on
| 2016 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024110
