UMIN-CTR Clinical Trial

Basic information
Public title	Associations of socio-economic status with oral health among adults: An observational study
Acronym	Associations of socio-economic status with oral health among adults: An observational study
Scientific Title	Associations of socio-economic status with oral health among adults: An observational study
Scientific Title:Acronym	Associations of socio-economic status with oral health among adults: An observational study
Region	Japan

Condition
Condition	Oral disease
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study is to examine the association between socio-economic status and oral health.
Basic objectives2	Others
Basic objectives -Others	The purpose of the study is to examine the association between socio-economic status and general health status.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of tooth loss
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	34 years-old >=
Gender	Male and Female
Key inclusion criteria	20-34 years old
Key exclusion criteria	under 19 years old or over 35 years old
Target sample size	7500

Research contact person
Name of lead principal investigator	1st name Ken Osaka, Yukihiro Sato Middle name Last name Ken Osaka, Yukihiro Sato
Organization	Tohoku University Graduate School of Dentistry
Division name	Department of International and Community Oral Health
Zip code	980-8575
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	022-717-7639
Email	kksi.sato@gmail.com

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Sato
Organization	Tohoku University Graduate School of Dentistry
Division name	Department of International and Community Oral Health
Zip code	9808575
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	022-717-7639
Homepage URL
Email	kksi.sato@gmail.com

Sponsor
Institute	Tohoku university
Institute
Department

Funding Source
Organization	Tohoku university Division for Interdisciplinary Advanced Research and Education
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	Ethics Committee Tohoku University Graduate School of Dentistry
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel	022-717-8244
Email	den-syom@grp.tohoku.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 11 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	2017 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date	2017 Year 11 Month 22 Day
Date of closure to data entry	2017 Year 11 Month 24 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Self-reported questionnaires

Management information
Registered date	2017 Year 11 Month 13 Day
Last modified on	2019 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034102