UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016599 |
|---|---|
| Receipt number | R000019264 |
| Scientific Title | A survey of the care effect with appropriate toothbrush choice for people in a hospital or a nursing home |
| Date of disclosure of the study information | 2015/02/22 |
| Last modified on | 2017/08/25 11:21:33 |
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Basic information
Public title
A survey of the care effect with appropriate toothbrush choice for people in a hospital or a nursing home
Acronym
Care effect with appropriate choice of toothbrush
Scientific Title
A survey of the care effect with appropriate toothbrush choice for people in a hospital or a nursing home
Scientific Title:Acronym
Care effect with appropriate choice of toothbrush
Region
| Japan |
Condition
Condition
gingivitis
Classification by specialty
| Dental medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the care effect with appropriate choice of toothbursh
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gingival Index
Key secondary outcomes
dry mouth condition
oral mucosal condition
the number of times of tooth brushing
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
At first, we do the dental check up for all target people. Then, provide appropriate toothbrush for intervention group. After a month, we check up them again and evaluate oral hygiene states.
Interventions/Control_2
In control group, we do the dental check up and oral care by usual toothbrush. After a month, we check up them again and evaluate oral hygiene states.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People in a hospital or a nursing home
Key exclusion criteria
Endentulous people
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mami Endoh |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Dentistry for the Disabled
Zip code
Address
2-870-1,Sakaecho-Nishi Matsudo City,Chiba 271-8587,Japan
TEL
047-360-9443
endoh.mami@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jumpei Kubota |
Organization
Kyushu Dental University
Division name
Division of Special Needs and Geriatric Dentistry
Zip code
Address
2-6-1,Manazuru Kokurakita-ku Kitakyushu,803-8580,Japan
TEL
093-582-1131(093-285-3074)
Homepage URL
r10kubota@live.jp
Sponsor or person
Institute
Division of Special Needs and Geriatric Dentistry, Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
北九州中央病院など
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 22 | 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
| 2014 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 22 | Day |
Last modified on
| 2017 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019264
