UMIN-CTR Clinical Trial

Basic information
Public title	survey of tooth wear among wide-age ranged adults
Acronym	survey of tooth wear among wide-age ranged adults
Scientific Title	cross-sectional survey for age-specific prevalence of tooth wear
Scientific Title:Acronym	cross-sectional survey for age-specific prevalence of tooth wear
Region	Japan

Condition
Condition	tooth wear
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the prevalence of tooth wear among wide-age ranged adults
Basic objectives2	Others
Basic objectives -Others	cross-sectional survey
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	prevalence of tooth wear
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	18 years-old <=
Age-upper limit	89 years-old >=
Gender	Male and Female
Key inclusion criteria	good health, ability to understand and read the questionnaire, a minimum of four eligible teeth (without restorations)
Key exclusion criteria	wearing orthodontic appliances, the presence of trismus, the presence of full coverage restorations on any of the four minimum present teeth, taking analgesics or oral local anesthesia in the last 24 h
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Junji Middle name Last name Tagami
Organization	Tokyo Medical and Dental University
Division name	Cariology and Operative Dentistry
Zip code	113-8549
Address	5-45 Yushima 1-chome, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5483
Email	tagami.ope@tmd.ac.jp

Public contact
Name of contact person	1st name Yuichi Middle name Last name Kitasako
Organization	Tokyo Medical and Dental University
Division name	Cariology and Operative Dentistry
Zip code	113-8549
Address	5-45 Yushima 1-chome, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5483
Homepage URL
Email	kitasako.ope@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	None
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	Tokyo Medical and Dental University
Address	5-45 Yushima 1-chome, Bunkyo-ku, Tokyo, Japan
Tel	03-5803-5483
Email	kitasako.ope@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	2020 Year 10 Month 02 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1108
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	Main results already published
Date of protocol fixation	2011 Year 09 Month 02 Day
Date of IRB	2011 Year 09 Month 02 Day
Anticipated trial start date	2011 Year 09 Month 02 Day
Last follow-up date	2030 Year 10 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	cross-sectional survey

Management information
Registered date	2020 Year 10 Month 02 Day
Last modified on	2020 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047916