UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028107 |
|---|---|
| Receipt number | R000032000 |
| Scientific Title | EVALUATION OF THE EFFECTIVENESS OF SCHOOL BASED ORAL HEALTH PROMOTION PROGRAM IN MYANMAR |
| Date of disclosure of the study information | 2017/07/06 |
| Last modified on | 2019/02/12 15:59:04 |
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Basic information
Public title
EVALUATION OF THE EFFECTIVENESS OF SCHOOL BASED ORAL HEALTH PROMOTION PROGRAM IN MYANMAR
Acronym
EVALUATION OF THE EFFECTIVENESS OF SCHOOL BASED ORAL HEALTH PROMOTION PROGRAM IN MYANMAR
Scientific Title
EVALUATION OF THE EFFECTIVENESS OF SCHOOL BASED ORAL HEALTH PROMOTION PROGRAM IN MYANMAR
Scientific Title:Acronym
EVALUATION OF THE EFFECTIVENESS OF SCHOOL BASED ORAL HEALTH PROMOTION PROGRAM IN MYANMAR
Region
| Asia(except Japan) |
Condition
Condition
Dental Public Health
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of oral health promotion program among Myanmar school children who received early intervention (one year oral health education program) and late intervention (six months oral health education program).
Basic objectives2
Others
Basic objectives -Others
To compare the questionnaires data and clinical data within group and between groups who are receiving early and late intervention (oral health education).
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Knowledge, attitude, practice and clinical skills will be improved after oral health education.
Key secondary outcomes
Preventive school oral health programs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Thirty minutes oral health education session concerned with dental caries, periodontal diseases and correct tooth brushing PowerPoint, video, pamphlets will be prepared and lectured to study group at baseline and 6 month time.. Early intervention group will receive oral health education at baseline and 6 month time.
Interventions/Control_2
Late intervention group will only receive oral health education at 6 month time. Teachers will be given prepared oral health education manual book. Once-a-month 10 minutes reinforced oral health education notice will be given by school teachers to both groups during second six months.
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
| 10 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Grade V (10-11) year old middle school students in two Townships
2. Both genders
3. School children who consented by parents or guardian to participate in this study
Key exclusion criteria
1. Children with uncooperative behavior and systemic diseases
Target sample size
362
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko KAWAGUCHI |
Organization
Tokyo Medical and Dental University, Japan
Division name
Dept. 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
+81-3-5803-5475
yoko.ohp@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zar Chi Kyaw Myint |
Organization
Tokyo Medical and Dental University, Japan
Division name
Dept. 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
+81-3-5803-5475
Homepage URL
kmzarchi@gmail.com
Sponsor or person
Institute
Department of Oral Health Promotion Graduate School of Medical and Dental Sciences,Tokyo Medical and Dental University, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Oral Health Promotion Graduate School of Medical and Dental Sciences,Tokyo Medical and Dental University, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
| 2017 | Year | 07 | Month | 06 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | 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
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032000
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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