UMIN-CTR Clinical Trial

Basic information
Public title	Epidemiological study on dental caries risk factors by evaluation of tooth surface hardness and oral environment
Acronym	Estimating caries risk due to tooth hardness
Scientific Title	Epidemiological study on dental caries risk factors by evaluation of tooth surface hardness and oral environment
Scientific Title:Acronym	Estimating caries risk due to tooth hardness
Region	Japan

Condition
Condition	Dental caries
Classification by specialty	Dental medicine Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the relationship between the risk of dental caries from the evaluation of tooth hardness and the oral environment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	occurrence of dental caries
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	3 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who attend regular dental checkup
Key exclusion criteria	Those who have a major illness in the oral cavity.
Target sample size	450

Research contact person
Name of lead principal investigator	1st name Takeyoshi Middle name Last name Koseki
Organization	Tohoku University Graduate School of Dentistry
Division name	Division of Proventive Dentistry
Zip code	980-8575
Address	4-1, Seiryomachi, Aobaku, Sendai, Miyagi, Japan
TEL	0227178326
Email	tkoseki@dent.tohoku.ac.jp

Public contact
Name of contact person	1st name Takeyoshi Middle name Last name Koseki
Organization	Tohoku University Graduate School of Dentistry
Division name	Division of Proventive Dentistry
Zip code	980-8575
Address	4-1, Seiryomachi, Aobaku, Sendai, Miyagi, Japan
TEL	0227178327
Homepage URL
Email	tkoseki@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
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	Tohiku University
Address	4-1, Seiryomachi, Aobaku, Sendai, Miyagi, Japan
Tel	0227178326
Email	tkoseki@dent.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	2021 Year 12 Month 10 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	Enrolling by invitation
Date of protocol fixation	2012 Year 12 Month 10 Day
Date of IRB	2022 Year 04 Month 11 Day
Anticipated trial start date	2022 Year 01 Month 01 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observe oral health at regular dental checkups.

Management information
Registered date	2021 Year 12 Month 09 Day
Last modified on	2022 Year 12 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052871