UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025676 |
|---|---|
| Receipt number | 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 | 2020/08/16 19:42:35 |
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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 | Masaru |
| Middle name | |
| Last name | Sugiyama |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Department of Public Oral Health
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5958
masaru@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Sugiyama |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Department of Public Oral Health
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5958
Homepage URL
masaru@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
Hiroshima University
Address
Kasumi1-2-3, Minami-ku, Hiroshima
Tel
082-257-5945
masaru@hiroshima-u.ac.jp
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
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000029536
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1186/s13690-018-0296-y
Number of participants that the trial has enrolled
9
Results
The mean PCR significantly decreased to 38.7 percent after 3 months of self-checked using disclosing solution compared with that before self-checking, 60.7 percent. PHP score significantly decreased to 1.4 at 4 months compared with that at baseline, 2.8 and 1 months, 2.7. Improvement of oral hygiene ratio was 0.4 plus-minus 0.35, range, 0.0-1.0. Significant correlation was not found between improvement rate and school grade.
Results date posted
| 2020 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
School children without untreated decayed teeth living in a children's home.
Participant flow
1. Oral hygiene instruction to the whole group
2. 1 month later: Individual tooth cleaning instruction
3. Self-care after plaque staining for 3 months.
4. Individual tooth cleaning instruction
5. 1 month later: Oral hygiene instruction
Adverse events
None
Outcome measures
PCR, PHP
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029536
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
