UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041099
Receipt No. 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 2020/07/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Shigeyuki
Middle name
Last name Nakaji
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 0172-39-5511
Email nakaji@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name Itoyo
Middle name
Last name Tokuda
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 0172-39-5511
Homepage URL
Email i-tokuda@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University COI
Institute
Department

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
Email 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 Preinitiation
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
2020 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046827

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.