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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047615
Receipt No. 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 2022/04/28

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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 Surgery in general Obsterics 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 022-717-8363
Email 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
Email atsuhiro.nagasaki.a5@tohoku.ac.jp

Sponsor
Institute Division of Molecular and Regenerative Prosthodontics, Tohoku University Graduate School of Dentistry
Institute
Department

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
Email 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

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 Preinitiation
Date of protocol fixation
2022 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 01 Day
Last follow-up date
2024 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
2022 Year 04 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_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


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