UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effect of makeup and cosmetic therapy with oral care and facial massage system
Acronym	A study on the effect of makeup and cosmetic therapy with oral care and facial massage system
Scientific Title	A study on the effect of makeup and cosmetic therapy with oral care and facial massage system
Scientific Title:Acronym	A study on the effect of makeup and cosmetic therapy with oral care and facial massage system
Region	Japan

Condition
Condition	Frailty
Classification by specialty	Rehabilitation medicine Dental medicine Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This research will develop an effective system that combines oral massage and cosmetic therapy using gels.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SEGE
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Massage and Cosmetic therapy and Oral care
Interventions/Control_2	Oral care
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	65 years-old <=
Age-upper limit	105 years-old >
Gender	Female
Key inclusion criteria	Hospitalized patients
Key exclusion criteria	cannot communicate
Target sample size	42

Research contact person
Name of lead principal investigator	1st name yasunori Middle name Last name sumi
Organization	National Center for Geriatrics and Gerontology
Division name	Division of Oral and Dental Surgery, Department of Advanced Medicine
Zip code	4748511
Address	Obu, Japan
TEL	(0562)46-2311
Email	yasusumi@ncgg.go.jp

Public contact
Name of contact person	1st name megumi Middle name Last name moriya
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Advanced Medicine Dentistry and Dental/Oral Surgery
Zip code	4748511
Address	Obu, Japan
TEL	(0562)46-2311
Homepage URL
Email	meg022@ncgg.go.jp

Sponsor
Institute	Division of Oral and Dental Surgery, Department of Advanced Medicine
Institute
Department

Funding Source
Organization	Division of Oral and Dental Surgery, Department of Advanced Medicine
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	Obu, Japan
Tel	0562462311
Email	meg022@ncgg.go.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	2019 Year 04 Month 01 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	2018 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 09 Day
Last modified on	2021 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038010