UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033762 |
|---|---|
| Receipt number | R000038511 |
| Scientific Title | Intervention survey on dental health behaviors and lifestyle of sports climbing/bouldering players |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2019/02/14 10:13:22 |
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Basic information
Public title
Intervention survey on dental health behaviors and lifestyle of sports climbing/bouldering players
Acronym
Intervention survey on dental health of sports climbing/bouldering players
Scientific Title
Intervention survey on dental health behaviors and lifestyle of sports climbing/bouldering players
Scientific Title:Acronym
Intervention survey on dental health of sports climbing/bouldering players
Region
| Japan |
Condition
Condition
Dental disease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Health education related to dentistry will be given to players actually doing sports climbing (bouldering) which is the new kind of the Tokyo Olympic Games. Questionnaire survey will be conducted before and after that in order to evaluate behavior change by the health education.
Basic objectives2
Others
Basic objectives -Others
Based on the result of the behavior change, we consider and propose intervention to the players by Dental professioals.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Behavioral change concerning intake of sports drink and/ or bevarages
Key secondary outcomes
Behavioral change concerning oral hygiene and/or health
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Health education for oral hygiene maintenance promotion
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
Sports climbing and/or sports bouldering players
Key exclusion criteria
Coaches and leaders (those who have not already played)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi CHUREI |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences, Department of Sports Medicine and Dentistry
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5867
chu.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi CHUREI |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences, Department of Sports Medicine and Dentistry
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5867
Homepage URL
chu.spmd@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
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
| 2018 | Year | 11 | 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
Results
1. The practitioner of sports climbing had little knowledge about dental health, and many of them told that they wanted to change their own dental health behavior by this health education. Therefore, it is expected that more dental health behavior of more sports climbers will be improved by increasing opportunities to contact dental and oral health information.
2. Among practitioners of sports climbing, there was a tendency that health educational program of this time was difficult to respond to those who practiced for only a few weeks or those who seemed to have poor dental health behavior. In order to raise the dental health in all of a person performing sports climbing, it is necessary that more aggressive activities about health education and approach which will echo those who did not spend time much to do sports climbing or beginners / those who are not interested in.
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
| 2018 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 14 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 14 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 14 | Day |
Other
Other related information
Tokyo Medical and Dental University
Faculty of Dentistry
School of Oral Health Care Sciences
Course for Oral Health Care Sciences
Graduation research
Management information
Registered date
| 2018 | Year | 08 | Month | 15 | Day |
Last modified on
| 2019 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038511
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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