UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041211 |
|---|---|
| Receipt number | R000047065 |
| Scientific Title | A study on cleaning effect of toothbrush containing black silica + MISWAK powder |
| Date of disclosure of the study information | 2020/08/15 |
| Last modified on | 2021/01/25 15:48:39 |
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Basic information
Public title
A study on cleaning effect of toothbrush containing black silica + MISWAK powder
Acronym
A study of effect of new toothbrush
Scientific Title
A study on cleaning effect of toothbrush containing black silica + MISWAK powder
Scientific Title:Acronym
A study of cleaning effect of newly developed toothbrush
Region
| Japan |
Condition
Condition
Poor oral cleaning
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of plaque removal effect of toothbrush containing black silica + MISWAK powder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plaque control record
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Toothbrushing with a toothbrush containing black silica + MISWAK powder
Interventions/Control_2
Toothbrushing with Black Silica + MISWAK powder-free 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Not suffering from periodontal disease
No missing teeth
Does not have significant dental malpractice
No functional impairment of fingers
Right handed
Non-Kanagawa Dental University students
Key exclusion criteria
Suffering from periodontal disease
Have missing teeth
There is a significant malpractice
Functional impairment of fingers
Left handed
Kanagawa Dental University student
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University, Graduate School of Dentistry
Division name
Department of Oral Science
Zip code
2388580
Address
82 Inaoka, Yokosuka, Kanagawa 2388580, Japan
TEL
81-46-822-8866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University, Graduate School of Dentistry
Division name
Department of Oral Science
Zip code
2388580
Address
82 Inaoka, Yokosuka, Kanagawa 2388580, Japan
TEL
81-46-822-8866
Homepage URL
tsukinoki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
SHINYEI KAISHA
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University
Address
82 Inaoka, Yokosuka, Kanagawa 2388580, Japan
Tel
0468228755
graduate@kdu.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 15 | 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
| 2020 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 26 | Day |
Last modified on
| 2021 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047065
