UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047615 |
|---|---|
| Receipt number | R000054291 |
| Scientific Title | To clarify the relationship between frailty and oral hypofunction: epidemiological research |
| Date of disclosure of the study information | 2022/05/02 |
| Last modified on | 2024/05/02 13:59:21 |
* 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
To clarify the relationship between frailty and oral hypofunction: epidemiological research
Acronym
The relationship between frailty and oral hypofunction
Scientific Title
To clarify the relationship between frailty and oral hypofunction: epidemiological research
Scientific Title:Acronym
The relationship between frailty and oral hypofunction: epidemiological research
Region
| Japan |
Condition
Condition
Frailty, Oral hypofunction
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
| Surgery in general | Obstetrics and Gynecology | Ophthalmology |
| Dermatology | Psychiatry | Oto-rhino-laryngology |
| Orthopedics | Urology | Oral surgery |
| Neurosurgery | Cardiovascular surgery | Laboratory medicine |
| Rehabilitation medicine | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between physical condition/systemic disease and oral hypofunction
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between physical condition/systemic disease and oral hypofunction
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Clarify the relationship between physical condition/systemic disease and oral hypofunction
Evaluation items: Medical examination records and dental/oral examination records
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are suspected of oral hypofunction
Key exclusion criteria
1. Patients whose tooth may be lost by the oral examination due to the diseases such as sever periodontitis
2. Patients who have the difficulty of swallowing and the possible of accidental ingestion and aspiration
3. Patients who have an ill-fitting prosthetic appliance such as denture resulting in corruption
4. Patients who have an allergy to the materials of this oral examination
5. Patients who are advised not to join this study by dentist or medical doctor
6. Patients who have a mental disorder and are advised not to join this study by dentist or medical doctor
7. Patients who have the difficulty of communication due to the disorders such as severe dementia and are advised not to join this study by dentist or medical doctor and/or the patients or their legal representative do not agree with joining this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Egusa |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Molecular and Regenerative Prosthodontics
Zip code
980-8575
Address
4-1, Seiryouchou, Aoba-ku, Sendai, Miyagi, Japan, 980-8575
TEL
022-717-8364
hiroshi.egusa.e2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Nagasaki |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Molecular and Regenerative Prosthodontics
Zip code
980-8575
Address
4-1, Seiryouchou, Aoba-ku, Sendai, Miyagi, Japan, 980-8575
TEL
022-717-8363
Homepage URL
atsuhiro.nagasaki.a5@tohoku.ac.jp
Sponsor or person
Institute
Division of Molecular and Regenerative Prosthodontics, Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology, Tohoku University Graduate School of Medicine
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ethics committee of Tohoku University Graduate School of Dentistry
Address
4-1, Seiryouchou, Aoba-ku, Sendai, Miyagi, Japan, 980-8575
Tel
022-728-4105
ec_den@rinri.hosp.tohoku.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 02 | 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
| 2022 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who will receive prosthodontic treatment such as wearing new denture or receive periodontal treatment should have the oral examination before and after the treatment to evaluate the effects of the treatments.
Management information
Registered date
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054291
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
