UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060597 |
|---|---|
| Receipt number | R000069311 |
| Scientific Title | Clinical evaluation of a 16-branched filament toothbrush with a pressure-reducing mechanism |
| Date of disclosure of the study information | 2026/02/09 |
| Last modified on | 2026/02/06 10:19:18 |
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Basic information
Public title
Efficacy study of toothbrushes
Acronym
Efficacy study of toothbrushes
Scientific Title
Clinical evaluation of a 16-branched filament toothbrush with a pressure-reducing mechanism
Scientific Title:Acronym
Clinical evaluation of a 16-branched filament toothbrush with a pressure-reducing mechanism
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare dental plaque removal effectiveness and brushing pressure among test samples.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Dental plaque removal rate
Key secondary outcomes
Brushing pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Brush teeth for approximately 3 minutes using test toothbrush A.
Interventions/Control_2
Brush teeth for approximately 3 minutes using test toothbrush B.
Interventions/Control_3
Brush teeth for approximately 3 minutes using test toothbrush C.
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
Aged 20 years or older.
Written informed consent was obtained from the participant after a full explanation using the informed consent document.
Brushing pressure of 200 g or greater as measured by a toothbrushing pressure indicator (Komatsu Co., Ltd., Tokyo, Japan).
Presence of 14 or more test teeth.
Key exclusion criteria
Use of dentures.
Undergoing orthodontic treatment.
Presence of significant malocclusion.
Presence of severe dental caries.
Scheduled dental clinic visits during the study period.
Known allergy to dental plaque disclosing solution components.
Individuals deemed ineligible by the study investigator or the study dentist.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Suzuki |
Organization
Sunstar Foundation
Division name
Sunstar Foundation Senri Dental Clinic
Zip code
560-0082
Address
SENRITO Yomiuri 3F, 1-1-3 Shin-Senri Higashimachi, Toyonaka, Osaka, Japan
TEL
06-6834-1582
hidenori.suzuki@sunstar.com
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Ibaraki |
Organization
Sunstar Foundation
Division name
Department of Oral Health
Zip code
569-1133
Address
1-35-10 Kawanishi-cho, Takatsuki, Osaka, Japan
TEL
072-682-7298
Homepage URL
hiroko.ibaraki@sunstar.com
Sponsor or person
Institute
Sunstar Foundation
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc.
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
Validity Evaluation Committee, Sunstar Inc.
Address
Asia One Center 8F, 1-17 Koyochonaka, Higashinada-ku, Kobe, Hyogo, Japan
Tel
080-8335-9125
takeshi.kanamori@sunstar.com
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
サンスター株式会社（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069311
