UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037577 |
|---|---|
| Receipt number | R000042840 |
| Scientific Title | Examination of plaque removal efficiency using high density flocked electric toothbrush "Curaprox Hydrosonic Pro" |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2019/08/02 01:10:40 |
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Basic information
Public title
Research of electric toothbrush "Curaprox Hydrosonic Pro"
Acronym
Research of electric toothbrush
Scientific Title
Examination of plaque removal efficiency using high density flocked electric toothbrush "Curaprox Hydrosonic Pro"
Scientific Title:Acronym
Examination of plaque removal efficiency using electric toothbrush
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the plaque removal efficiency of various electric toothbrushes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plaque index (PlI), Gingival index (GI),
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using electric toothbrush "Curaprox Hydrosnic Pro" for teeth in quadrant
Interventions/Control_2
Using electric toothbrush "S" for teeth in quadrant
Interventions/Control_3
Using electric toothbrush "O" for teeth in quadrant
Interventions/Control_4
Using manual toothbrush "Curaprox" for teeth in quadrant
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.The staff at the department of periodontology at Tokyo Medical and Dental University (TMDU)
2. 20 or more remaining teeth
Key exclusion criteria
1. Having a serious systemic disease or infection
2. During pregnancy or nursing period
3. Having acute periodontal disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Medical and dentalUniversity
Division name
Depertment of Periodontology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5488
ikeda.peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Medical and dentalUniversity
Division name
Depertment of Periodontology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5488
Homepage URL
ikeda.peri@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
YOSHIDA DENTAL TRADE DISTRIBUTION CO., LTD
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
Tokyo Medical and dentalUniversity
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5488
ikeda.peri@tmd.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
東京医科歯科大学歯学部附属病院 歯周病外来
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 08 | Month | 02 | Day |
Last modified on
| 2019 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042840
