UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050249 |
|---|---|
| Receipt number | R000057212 |
| Scientific Title | Study on effect of an electric toothbrush with monitor in dental plaque removal |
| Date of disclosure of the study information | 2023/02/07 |
| Last modified on | 2023/02/06 20:20:27 |
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Basic information
Public title
Study on effect of an electric toothbrush with monitor in dental plaque removal
Acronym
Proving test of an electric toothbrush with monitor
Scientific Title
Study on effect of an electric toothbrush with monitor in dental plaque removal
Scientific Title:Acronym
Proving test of an electric toothbrush with monitor
Region
| Japan |
Condition
Condition
gingivitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the plaque removal effect of a prototype device that has a built-in image sensor in the head of an electric toothbrush, enabling the user to brush while checking the condition of the tooth surface on a monitor in real time, and to assess their sense of use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the rate of plaque removal after use.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of electric toothbrush with image sensor
Interventions/Control_2
Use of electric toothbrush without image sensor
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Fifth-year dental student
Key exclusion criteria
Subjects who have injury of gingiva by new electronic toothbrush
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Sakagami |
Organization
Fukuoka Dental College
Division name
Department of Periodontology
Zip code
8140193
Address
2-15-1, Tamura, Sawara-ku, Fukuoka
TEL
092-801-0411
sakagami@fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Yoshinaga |
Organization
Fukuoka Dental College
Division name
Department of Periodontology
Zip code
8140193
Address
2-15-1, Tamura, Sawara-ku, Fukuoka
TEL
092-801-0411
Homepage URL
yoshiyasu@fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Dental College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
HA-PPY Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Dental College
Address
2-15-1, Tamura, Sawara-ku, Fukuoka
Tel
092-801-0411
yoshiyasu@fdcnet.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
| 2023 | Year | 02 | Month | 07 | 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
10
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
| 2018 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 06 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057212
