UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024778 |
|---|---|
| Receipt number | R000028506 |
| Scientific Title | Survey on the prevention of oral diseases |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2020/05/20 18:33:58 |
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Basic information
Public title
Survey on the prevention of oral diseases
Acronym
Survey on the prevention of oral diseases
Scientific Title
Survey on the prevention of oral diseases
Scientific Title:Acronym
Survey on the prevention of oral diseases
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years national medical expenses, due to the increase by 1 billion each year, there is a growing importance of prevention. In, which is also touted the importance of prevention in the dental field, workers who are busy in day-to-day duties, dental treatment is tend to become secondary. Therefore when the prominent symptoms in the oral cavity (pain, upset, etc.) is not from appearing without visit to the dentist's office, a result there is a case in which saving the tooth becomes impossible. In addition the treatment is hard to do even early detection and early treatment of the disease for retention rate is also low of regular checkups after the end (maintenance).
Therefore, in the present study examines the awareness and need for dental treatment of people falls on working people, to establish the system and educational activities to improve the participation rate of regular checkups, it aims to clarify the role as a regional primary care physician to.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Three times every six months the state to caries, periodontal disease from the oral cavity in the examination for the first time by the intra-oral examination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Other |
Interventions/Control_1
Use the disposable paper tray, the probe and the mirror tweezers probe rubber gloves, perform the intra-oral examination. Also make the toothpaste guidance using a hand mirror, toothbrush. The period of intervention and two years, frequency and once in six months.
Interventions/Control_2
Use the disposable paper tray, the probe and the mirror tweezers probe rubber gloves, perform the intra-oral examination.The duration of the intervention shall be two years and the frequency shall be once every six months. This group is used as a control group.
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Workers in Osaka Prefecture belonging to the service industry, transportation industry, manufacturing industry, small businesses and individual shops among those who are not visiting dental clinics
Key exclusion criteria
Persons who are visiting a dental office, people with mental illness, people with movement disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Okinori |
| Middle name | |
| Last name | Shikura |
Organization
Matsumoto Dental University Institute /Dentistry independent Graduate School
Division name
hin oral function control Laboratory /Biological regulation control studies
Zip code
399-0781
Address
Nagano Prefecture Shiojiri Hirookagobara 1780
TEL
080-8923-9797
o.shikura@outlook.jp
Public contact
Name of contact person
| 1st name | Okinori |
| Middle name | |
| Last name | Shikura |
Organization
Matsumoto Dental University Institute /Dentistry independent Graduate School
Division name
Chin oral function control Laboratory /Biological regulation control studies
Zip code
399-0781
Address
Nagano Prefecture Shiojiri Hirookagobara 1780
TEL
080-8923-9797
Homepage URL
o.shikura@outlook.jp
Sponsor or person
Institute
Matsumoto Dental University Institute /Dentistry independent Graduate School
Institute
Department
Personal name
Funding Source
Organization
Matsumoto Dental University Institute /Dentistry independent Graduate School
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
Matsumoto Dental University Institute /Dentistry independent Graduate School
Address
Nagano Prefecture Shiojiri Hirookagobara 1780
Tel
0263-51-2188
info_kakenhi@po.mdu.ac.jp
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 | 12 | Month | 01 | 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
21
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
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
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 | 09 | Day |
Last modified on
| 2020 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028506
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