UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study on the implementation of oral function improvement services by dental hygienists for users of nursing care elderly health facility Watatsumi Day Service
Acronym	Intervention study on the implementation of oral function improvement services
Scientific Title	Intervention study on the implementation of oral function improvement services by dental hygienists for users of nursing care elderly health facility Watatsumi Day Service
Scientific Title:Acronym	Intervention study on the implementation of oral function improvement services
Region	Japan

Condition
Condition	None
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to investigate all the facility users and to grasp the current situation, and to provide oral function improvement services to the target persons with the aim of improving oral function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Oral Diadocokinesis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Provision of individual oral function improvement services by dental hygienists
Interventions/Control_2	Provision of overall oral function improvement services by dental hygienists
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Persons who need support 1 or 2 of the elderly health care facility Watatsumi Day Care users and who have consented to this study
Key exclusion criteria	Those who did not obtain consent for this study People over 100 years old
Target sample size	100

Research contact person
Name of lead principal investigator	1st name MIHO Middle name Last name MANABE
Organization	Mitoyo General Hospital
Division name	Department of Dental Hygiene
Zip code	769-1695
Address	708 Himehama, Toyohama-cho, Kannonji City, Kagawa Prefecture
TEL	0875-52-3366
Email	candypop_666@yahoo.co.jp

Public contact
Name of contact person	1st name MIHO Middle name Last name MANABE
Organization	Mitoyo General Hospital
Division name	Department of Dental Hygiene
Zip code	769-1695
Address	708 Himehama, Toyohama-cho, Kannonji City, Kagawa Prefecture
TEL	0875523366
Homepage URL
Email	candypop_666@yahoo.co.jp

Sponsor
Institute	Mitoyo General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Mitoyo General Hospital
Address	708 Himehama, Toyohama-cho, Kannonji City, Kagawa Prefecture
Tel	0875-52-3366
Email	candypop_666@yahoo.co.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 11 Month 08 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	2019 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date	2019 Year 11 Month 11 Day
Last follow-up date	2021 Year 11 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 08 Day
Last modified on	2019 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043905