UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041099 |
|---|---|
| Receipt number | R000046827 |
| Scientific Title | Oral health education for parents to improve oral hygiene of infants |
| Date of disclosure of the study information | 2020/07/14 |
| Last modified on | 2024/04/08 19:20:36 |
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Basic information
Public title
Oral health education for parents to improve oral hygiene of infants
Acronym
Mother-child oral hygiene improvement trial
Scientific Title
Oral health education for parents to improve oral hygiene of infants
Scientific Title:Acronym
Mother-child oral hygiene improvement trial
Region
| Japan |
Condition
Condition
Oral hygiene
Classification by specialty
| Dental medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By providing oral health education for parents, improve oral hygiene literacy of parents. As a result, the consciousness and technique of brushing the teeth of the child are improved.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dental condition (3 months, 1.5 y.o., 2 y.o., 3 y.o.) at the time of infant health checkup (cavities, gums, mucosa, biting, etc.)
Key secondary outcomes
Growth status (3 months, 1.5 y.o., 2 y.o., 3 y.o.) at the time of infant checkup (height, weight, nutritional status, how to grow teeth, oral care status, eating habits, finger sucking, etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Oral health education based on the oral condition of the parent at the time of infant medical examination.
Interventions/Control_2
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
| 3 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The infants and their parents who take infant health examination, and agree to informed consent
Key exclusion criteria
none
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | MIKAMI |
Organization
Hirosaki University Graduate School of Medicine
Division name
Innovation Center for Health Promotion
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki City, Aomori Prefecture
TEL
0172-39-5037
tmika@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | SAWADA |
Organization
Hirosaki University Graduate School of Medicine
Division name
Innovation Center for Health Promotion
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki City, Aomori Prefecture
TEL
0172-39-5450
Homepage URL
iwane@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University COI
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Hirosaki University Grauate School of Medicine
Address
5 Zaifu-cho, Hirosaki City, Aomori Prefecture
Tel
0172-39-5043
rinri@hirosaki-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
スポカルイン黒石
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046827
| 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 |
