UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study to evaluate the difference between subjective awareness an examination for oral function
Acronym	A clinical study to evaluate the difference between subjective awareness an examination for oral function
Scientific Title	A clinical study to evaluate the difference between subjective awareness an examination for oral function
Scientific Title:Acronym	A clinical study to evaluate the difference between subjective awareness an examination for oral function
Region	Japan

Condition
Condition	oral hypofunction
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To understand the degree of awareness of oral function among local residents and whether there is a difference between the degree of awareness by the researcher and the results of oral function examination conducted by medical professionals.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences in the proportion of oral dysfunction based on the degree of awareness by the research subjects and the test results by the medical person
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Other
Interventions/Control_1	Oral function screening test
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	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who live in Saga City over 20 years old and visit Mise Clinic
Key exclusion criteria	1. Under 20 years old 2. Those who have determined that the person in charge of research cannot be examined due to abnormalities in the vocal ability or response ability 3. Those who have undergone any examination to determine hypoorobia 4. Those who have been tested for oral freil judgment 5. Those who have determined that the person in charge of research is inappropriate as a research subject
Target sample size	105

Research contact person
Name of lead principal investigator	1st name Shoko Middle name Last name Tsuruoka
Organization	Saga Municipal National Health Insurance Mitsuse Clinic
Division name	dental
Zip code	8420302
Address	3882-6 fujiwara, mitsuse, saga city
TEL	0952562001
Email	sn8129@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Shoko Middle name Last name Tsuruoka
Organization	Saga Municipal National Health Insurance Mitsuse Clinic
Division name	dental
Zip code	8420302
Address	3882-6 fujiwara, mitsuse, saga city
TEL	0952562001
Homepage URL
Email	sn8129@cc.saga-u.ac.jp

Sponsor
Institute	Saga Municipal National Health Insurance Mitsuse Clinic
Institute
Department

Funding Source
Organization	Saga Municipal National Health Insurance Mitsuse Clinic
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	Japanese society of gerodontology IRB
Address	1-43-9 komagome, toyoshimaku, tokyo
Tel	0339478891
Email	gakkai30@kokuhoken.or.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	2022 Year 01 Month 17 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	Open public recruiting
Date of protocol fixation	2019 Year 05 Month 31 Day
Date of IRB	2019 Year 05 Month 31 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 17 Day
Last modified on	2022 Year 01 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053230