UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050802 |
|---|---|
| Receipt number | R000057891 |
| Scientific Title | Safety and clinical evaluation of sonic tongue brush |
| Date of disclosure of the study information | 2023/04/10 |
| Last modified on | 2023/04/10 14:58:22 |
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Basic information
Public title
Safety and clinical evaluation of sonic tongue brush
Acronym
clinical evaluation of sonic tongue brush
Scientific Title
Safety and clinical evaluation of sonic tongue brush
Scientific Title:Acronym
clinical evaluation of sonic tongue brush
Region
| Japan |
Condition
Condition
halitosis, aspiration pneumonia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, a novel tongue-cleaning utensil utilizing sonic vibration has been developed.However, its effectiveness in removing tongue coating and its impact on the tongue and bacteria have not yet been evaluated.This study used a manual tongue brush and the newly developed sonic tongue brush and comparatively evaluated the removal of tongue coating, damage to the tongue, pain during use, and bacterial count on the dorsum linguae.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Tongue coating amount, bacterial count evaluation, and tongue surface evaluation before and after using the sonic tongue brush and tongue brush
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
each patient was asked to clean the region extending from the lingual root to lingual apex by moving this brush back and forth for 2 min using the newly developed sonic tongue brush.
Interventions/Control_2
each patient was asked to clean the region extending from the lingual root to lingual apex by moving this brush back and forth for 2 min using a manual tongue brush.
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
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients without periodontal disease
Key exclusion criteria
the patients with periodontal disease
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Shirakawa |
Organization
Tsurumi University
Division name
Department of Dental Hygiene, Tsurumi Junior College
Zip code
230-8501
Address
2-1-3 Tsurumi-ku, Yokohama-shi, KANAGAWA
TEL
045-580-8178
shirakawa-satoshi@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Shirakawa |
Organization
Tsurumi University
Division name
Department of Dental Hygiene, Tsurumi Junior College
Zip code
230-8501
Address
2-1-3 Tsurumi-ku, Yokohama-shi, KANAGAWA
TEL
045-580-8178
Homepage URL
shirakawa-satoshi@tsurumi-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Kazuhiro Gomi
Funding Source
Organization
None
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
Tsurumi University
Address
2-1-3 Tsurumi-ku, Yokohama-shi, KANAGAWA
Tel
045-580-8178
shirakawa-satoshi@tsurumi-u.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 | 04 | Month | 10 | 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
14
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to unanalyzed data
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 | 04 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 20 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057891
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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