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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028107
Receipt No. 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

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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
Email 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
Email kmzarchi@gmail.com

Sponsor
Institute Department of Oral Health Promotion Graduate School of Medical and Dental Sciences,Tokyo Medical and Dental University, Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032000

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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