UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044996 |
|---|---|
| Receipt number | R000047455 |
| Scientific Title | The study of the effective mouth rinsing methods as functional oral rehabilitation |
| Date of disclosure of the study information | 2021/07/29 |
| Last modified on | 2021/07/29 14:00:12 |
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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
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
endoh.mami@nihon-u.ac.jp
Sponsor or person
Institute
Nihon university dentistry at Matsudo, Department of special needs dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047455
