UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046662
Receipt number R000053230
Scientific Title A clinical study to evaluate the difference between subjective awareness an examination for oral function
Date of disclosure of the study information 2022/01/17
Last modified on 2022/01/17 17:13:37

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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 or person

Institute

Saga Municipal National Health Insurance Mitsuse Clinic

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053230


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name