UMIN-CTR Clinical Trial

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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