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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025676
Receipt No. R000029536
Scientific Title Establishment of a dental health guidance method for primary and secondary school students in cildren's homes
Date of disclosure of the study information 2017/01/16
Last modified on 2017/01/14

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Basic information
Public title Establishment of a dental health guidance method for primary and secondary school students in cildren's homes
Acronym A dental health guidance method for primary and secondary school students
Scientific Title Establishment of a dental health guidance method for primary and secondary school students in cildren's homes
Scientific Title:Acronym A dental health guidance method for primary and secondary school students
Region
Japan

Condition
Condition Caries and gingivitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate changes of an attitude to oral health and establish a dental health guidance method for students in children's home.
Basic objectives2 Others
Basic objectives -Others Investigation of an attitude to oral health and establishment of a dental health guidance method
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PCR score at 3 months after starting self-chek of dental plaque
Key secondary outcomes PHP score at 3 months after starting self-chek of dental plaque

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Students brush their teeth using a stain solution for dental plaque at a children's home.
Interventions/Control_2 Students brush their teeth without using a stain solution for dental plaque at the other children's home.
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
6 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Primary and secondary students, who can communicate their minds to others, at 2 children's homes
Key exclusion criteria Students are treated by an orthodontist or have less than 6 teeth excluding residual roots.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Sugiyama
Organization Hiroshima University, Institute of Biomedical & Health Sciences
Division name Department of Public Oral Health
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5958
Email masaru@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Sugiyama
Organization Hiroshima University, Institute of Biomedical & Health Sciences
Division name Department of Public Oral Health
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5958
Homepage URL
Email masaru@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima 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
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 01 Month 16 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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 11 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 01 Month 14 Day
Last modified on
2017 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029536

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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