UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	EVALUATION OF THE EFFECTIVENESS OF SCHOOL BASED ORAL HEALTH PROMOTION PROGRAM IN MYANMAR
Title of the study (Brief title)	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	Yoko KAWAGUCHI
Organization	Tokyo Medical and Dental University, Japan
Division name	Dept. of Oral Health Promotion Graduate School of Medical and Dental Sciences
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	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
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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