UMIN-CTR Clinical Trial

Basic information
Public title	The study of the effective mouth rinsing methods as functional oral rehabilitation
Acronym	The study of the functional oral rehabilitation by mouth rinsing
Scientific Title	The study of the effective mouth rinsing methods as functional oral rehabilitation
Scientific Title:Acronym	The study of the functional oral rehabilitation by mouth rinsing
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to determine whether some kinds of mouth rinsing are effective for improving the oral hypofunction among the elderly people.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lips pressure
Key secondary outcomes	Dry mouth condition Speaking function tongue pressure etc.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	The group 1 is to do mouth rinsing with just water among 10 seconds.
Interventions/Control_2	The group 2 is to do mouth rinsing with bubbled liquid toothpaste among 10 seconds.
Interventions/Control_3	The group 3 as control group is not given any instructs.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Dental outpatients 2)Oral hypofunction
Key exclusion criteria	1)The elderly who staying in nursing homes or hospitals 2)Having oral cancer, 3)Received intraoral radiation therapy at any time in the past 4)Having salivary gland disease.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Mami Middle name Last name Endoh
Organization	Nihon university dentistry at Matsudo
Division name	Department of special needs dentistry
Zip code	271-8587
Address	2-870-1, Sakae cho- nishi, Matsudo City, Chiba prefecture, Japan
TEL	047-360-9443
Email	endoh.mami@nihon-u.ac.jp

Public contact
Name of contact person	1st name Mami Middle name Last name Endoh
Organization	Nihon university dentistry at Matsudo
Division name	Department of special needs dentistry
Zip code	271-8587
Address	2-870-1, Sakae cho- nishi, Matsudo City, Chiba prefecture, Japan
TEL	047-360-9443
Homepage URL
Email	endoh.mami@nihon-u.ac.jp

Sponsor
Institute	Nihon university dentistry at Matsudo, Department of special needs dentistry
Institute
Department

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

Other related organizations
Co-sponsor	Asada Denal Oral Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon university dentistry at Matsudo
Address	Department of special needs dentistry
Tel	047-360-9443
Email	endoh.mami@nihon-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	あさだ歯科医院（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 29 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	Enrolling by invitation
Date of protocol fixation	2021 Year 05 Month 02 Day
Date of IRB	2021 Year 06 Month 24 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2022 Year 08 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	2021 Year 07 Month 29 Day
Last modified on	2021 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047455