UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020361 |
|---|---|
| Receipt number | R000023520 |
| Scientific Title | Clinical trial to examine the usefulness of rotary toothbrush for caring compared to regular toothbrush |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2019/04/18 18:43:13 |
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Basic information
Public title
Clinical trial to examine the usefulness of rotary toothbrush for caring compared to regular toothbrush
Acronym
Clinical trial to examine the usefulness of rotary toothbrush for caring
Scientific Title
Clinical trial to examine the usefulness of rotary toothbrush for caring compared to regular toothbrush
Scientific Title:Acronym
Clinical trial to examine the usefulness of rotary toothbrush for caring
Region
| Japan |
Condition
Condition
Persons who attend to Elderly welfare facility
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of usefulness of rotary toothbrush
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plaque removal effect after use; Plaque Control Record, Patient Hygiene Performance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For persons who attend to Elderly welfare facility, care with either regular toothbrush or rotary toothbrush.
Interventions/Control_2
For persons who attend to Elderly welfare facility, care with either regular toothbrush or rotary toothbrush.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Persons who attend to Elderly welfare facility with at least 5 teeth.
2) Persons who do not visit dental office for treatment.
3) Age not over 65.
4) Persons who agree to participate this study with document.
Key exclusion criteria
1) Persons who have orthodontic appliances in their oral.
2) Persons who do not open widely by temporomandibular disorder.
3) Persons who are difficult to communicate and violent with no reason.
4) Uncooperative person to the brushing.
5) Persons who have been determined not to be suitable as subjects of study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Sugiyama |
Organization
Hiroshima Univ.
Division name
Dept. of Public Oral Health
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-Shi, Hiroshima
TEL
082-257-5958
masaru@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Shimazu |
Organization
Hiroshima Univ.
Division name
Dept. of Oral Public Health, Hiroshima Univ.
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-Shi, Hiroshima
TEL
082-257-5945
Homepage URL
atsushi@hiroshima-u.ac.jp
Sponsor or person
Institute
Dept. of Public Oral Health, Hiroshima Univ.
Institute
Department
Personal name
Funding Source
Organization
non
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | 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
| 2015 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023520
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
