UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035300
Receipt number R000040218
Scientific Title A study on health literacy and oral health of high school students
Date of disclosure of the study information 2018/12/19
Last modified on 2019/12/25 15:42:13

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Basic information

Public title

A study on health literacy and oral health of high school students

Acronym

Health literacy and oral health of high school students

Scientific Title

A study on health literacy and oral health of high school students

Scientific Title:Acronym

Health literacy and oral health of high school students

Region

Japan


Condition

Condition

dental diseases

Classification by specialty

Dental medicine Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will investigate the effects on oral health education for preventive dentistry related health literacy of high school students.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

oral helth behavior

Key secondary outcomes

knowledge of oral helth


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

inform about oral health by leaflet (1 time)

Interventions/Control_2

not inform about oral health(control group)

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

16 years-old <=

Age-upper limit

17 years-old >=

Gender

Male and Female

Key inclusion criteria

high school students

Key exclusion criteria

persons are not high school students

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Kayoko
Middle name
Last name Shinada

Organization

Tokyo Medical and Dental University

Division name

Preventive oral health care science

Zip code

1138549

Address

Yushima1-5-45 Bunkyo-ku Tokyo

TEL

03-5803-4096

Email

shinada.ohp@tmd.ac.jp


Public contact

Name of contact person

1st name Kayoko
Middle name
Last name Shinada

Organization

Tokyo Medical and Dental University

Division name

Preventive oral health care science

Zip code

113-8549

Address

Yushima1-5-45 Bunkyo-ku Tokyo

TEL

03-5803-4096

Homepage URL


Email

shinada.ohp@tmd.ac.jp


Sponsor or person

Institute

Preventive oral health care science, Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Preventive oral health care science, Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental University

Address

1-5-45 Yushima Bunkyo-ku Tokyo Japan

Tel

0358034096

Email

shinada.ohp@tmd.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

2018 Year 12 Month 19 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

2018 Year 12 Month 20 Day

Date of IRB

2019 Year 04 Month 10 Day

Anticipated trial start date

2019 Year 04 Month 10 Day

Last follow-up date

2019 Year 10 Month 30 Day

Date of closure to data entry

2019 Year 12 Month 27 Day

Date trial data considered complete

2020 Year 01 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 12 Month 18 Day

Last modified on

2019 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040218


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name