UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026863 |
|---|---|
| Receipt number | R000030827 |
| Scientific Title | Effects of ultrasound toothbrushes on oral hygiene status |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2018/04/09 09:01:34 |
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Basic information
Public title
Effects of ultrasound toothbrushes on oral hygiene status
Acronym
Effects of ultrasound toothbrushes on oral hygiene status
Scientific Title
Effects of ultrasound toothbrushes on oral hygiene status
Scientific Title:Acronym
Effects of ultrasound toothbrushes on oral hygiene status
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Vascular surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the effects of ultrasound toothbrushes on oral hygiene status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral hygiene status: Plaque index (PlI), Gingival index (GI), Saliva flow rate.
Key secondary outcomes
Mental health (GHQ-30, POM2)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Group A: will use an examined toothbrush with power-off.
Interventions/Control_2
Group B: will use an examined toothbrush with ultrasound mood.
Interventions/Control_3
Group B: will receive professional oral prophylaxis and use an examined toothbrush with ultrasound mood.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Students who agree with this study.
Key exclusion criteria
Those who would not agree with the study. And those who had seen a psychiatrist, have periodontitis or severe gingivitis (GI>2.0), have active dental caries, or use a powered-toothbrush currently.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akane Takenouchi |
Organization
Taiyo School of Dental Hygiene
Division name
day-time class
Zip code
Address
Station Plaza Tower 6F, 2-22-1, Nishi-Nippori, Arakawa-ku, Tokyo, Japan
TEL
03-5810-8020
lisa_serugio4@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akane Takenouchi |
Organization
Taiyo School of Dental Hygiene
Division name
day-time class
Zip code
Address
Station Plaza Tower 6F, 2-22-1, Nishi-Nippori, Arakawa-ku, Tokyo, Japan
TEL
03-5810-8020
Homepage URL
lisa_serugio4@hotmail.co.jp
Sponsor or person
Institute
Taiyo School of Dental Hygiene
Institute
Department
Personal name
Funding Source
Organization
Taiyo School of Dental Hygiene
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
ITO CO.,LTD
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
| 2017 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2018 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030827
