UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation related to dental factor and cognitive function
Title of the study (Brief title)	Investigation related to dental factor and cognitive function
Region	Japan

Condition
Condition	All the diseases in the dental medicine field
Classification by specialty	Psychiatry Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of cognitive function in patients visiting dentists and investigation of dental medicine-associated factors
Basic objectives2	Others
Basic objectives -Others	Frequency stratified by cognitive function and influencing factors
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Examination of cognitive function:Japanese version of Montreal Cognitive Assessment (MoCA-J)
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)A Japanese patient aged >=65 years at the time his/her consent is acquired (2)A patient who gives his/her written consent after an explanation of the investigation
Key exclusion criteria	(1)A patient who has dementia or has been previously diagnosed with dementia (2) A patient who has or previously had cerebral stroke, schizophrenia or depression (3)A patient being treated with an antidementia, antidepressant, psychotropic or antianxiety drug (4)A patient other than the above whom a physician in charge of the investigation judges as ineligible for participation in the investigation
Target sample size	200

Research contact person
Name of lead principal investigator	Takeshi Yanase
Organization	Medical corporation Taihokai
Division name	Yanase Dental Clinic
Address	East Aray Bldg 4F. 1-3-9 Higashibenzai, Asaka-shi, Saitama, 351-0022, Japan
TEL	048-476-0156
Email	t-yanase@yanase-dental.com

Public contact
Name of contact person	Akiko Yokota
Organization	QOL RD Co.,Ltd.
Division name	Business Planning Division
Address	Front Place Nihonbashi Bldg.2-14-1,
TEL	03-6386-8807
Homepage URL
Email	a-yokota@qol-rd.co.jp

Sponsor
Institute	A public interest incorporated association The Japan Institute for Advanced Dentistry
Institute
Department

Funding Source
Organization	A public interest incorporated association The Japan Institute for Advanced Dentistry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 09 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 10 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective observational study

Management information
Registered date	2014 Year 09 Month 26 Day
Last modified on	2017 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017741