UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032973 |
|---|---|
| Receipt number | R000037600 |
| Scientific Title | The effectiveness of an oral health education on 12-13 years old school children. |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2018/06/13 17:35:59 |
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Basic information
Public title
The effectiveness of an oral health education on 12-13 years old school children.
Acronym
Effectiveness of oral health education on adolescents.
Scientific Title
The effectiveness of an oral health education on 12-13 years old school children.
Scientific Title:Acronym
Effectiveness of oral health education on adolescents.
Region
| Japan | Asia(except Japan) |
Condition
Condition
School children
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of Health Belief Model-based Oral health education on improving oral health knowledge, oral hygiene and oral health status of school children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral health knowledge, oral health practice and oral health status.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Behavior,custom |
Interventions/Control_1
Oral health education 2 times
Interventions/Control_2
Oral health education 1 time
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
| 11 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
secondary school children
Key exclusion criteria
1) children did not signed consent form, (2) children absent at baseline or in any intervention appointment
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nguyen Thi Nhat Vy |
Organization
Tokyo Medical and Dental University
Division name
Department of Oral Health Promotion, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan
TEL
08092055946
vy.ohp@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nguyen Thi Nhat Vy |
Organization
Tokyo Medical and Dental University
Division name
Department of Oral Health Promotion, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan
TEL
08092055946
Homepage URL
vy.ohp@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
| 2018 | Year | 09 | 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
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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | 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
| 2018 | Year | 06 | Month | 13 | Day |
Last modified on
| 2018 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037600
