UMIN-CTR Clinical Trial

Basic information
Public title	Impact of an oral care education to elderly people living in long-term nursing homes.
Acronym	Impact of an oral care education to elderly people living in long-term nursing homes.
Scientific Title	Impact of educational interventions on oral care to elderly people living in long-term nursing homes - pilot study.
Scientific Title:Acronym	Impact of educational interventions on oral care to elderly people living in long-term nursing homes.
Region	Japan

Condition
Condition	Oral hygiene
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to assess improvement of oral care interventions for elderly people who can do oral care by themselves living in nursing care facilities for the elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total score of Oral Assessment Guide in two weeks after intervention
Key secondary outcomes	Sub scores of Oral Assessment Guidein two weeks after intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	The intervention group directs oral care after baseline sampling. From the next day until the next sampling,the subject will perform oral cleaning for 2 minutes using a mucosal brush for oral care after lunch for 2 minutes.
Interventions/Control_2	The subject's in control do oral care by themselves as usual.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Persons who can do oral care by themselves with independence or with partial compensatory care.
Key exclusion criteria	Persons who can not do oral care by themselves at all.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kanetaka Middle name Last name Yamaguchi
Organization	Health Sciences University of Hokkaido
Division name	Division of Fixed Prosthodontics and Oral Implantology Department of Oral Rehabilitation
Zip code	061-0293
Address	1757 Kanazawa, Ishikari-Tobetsu Hokkaido 061-0293, JAPAN
TEL	0133232874
Email	k-yamaguchi@hoku-iryo-u.ac.jp

Public contact
Name of contact person	1st name Kanetaka Middle name Last name Yamaguchi
Organization	Health Sciences University of Hokkaido
Division name	Division of Fixed Prosthodontics and Oral Implantology Department of Oral Rehabilitation
Zip code	061-0293
Address	1757 Kanazawa, Ishikari-Tobetsu Hokkaido 061-0293, JAPAN
TEL	0133232874
Homepage URL
Email	k-yamaguchi@hoku-iryo-u.ac.jp

Sponsor
Institute	Health Sciences University of Hokkaido
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Division of Fixed Prosthodontics and Oral Implantology Department of Oral Rehabilitation
Address	1757 Kanazawa, Ishikari-Tobetsu Hokkaido 061-0293, JAPAN
Tel	0133232874
Email	k-yamaguchi@hoku-iryo-u.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	2020 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	2020 Year 05 Month 31 Day
Date of IRB	2020 Year 01 Month 21 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2021 Year 12 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	2020 Year 03 Month 31 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045604

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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