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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
