UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059049 |
|---|---|
| Receipt number | R000067529 |
| Scientific Title | Analysis of the Effectiveness of a Plaque Detecting Toothbrush |
| Date of disclosure of the study information | 2025/09/11 |
| Last modified on | 2025/09/10 16:23:53 |
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Basic information
Public title
Analysis of the Effectiveness of a Plaque Detecting Toothbrush
Acronym
Analysis of the Effectiveness of a Plaque Detecting Toothbrush
Scientific Title
Analysis of the Effectiveness of a Plaque Detecting Toothbrush
Scientific Title:Acronym
Analysis of the Effectiveness of a Plaque Detecting Toothbrush
Region
| Japan |
Condition
Condition
gingivitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dental caries is a prevalent disease during school age. For the prevention of dental caries, the acquisition of appropriate toothbrushing techniques and the enhancement of awareness regarding oral care are essential. The significance of this study lies in clarifying the effectiveness of a plaque-detecting toothbrush in reducing residual plaque and demonstrating its usefulness in supporting self-care at home. Furthermore, this study aims to provide practical insights that can be applied in clinical dentistry and preventive care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in PCR scores at each evaluation point (before the plaque-detecting toothbrush experiment and at the follow-up visit after 2-3 weeks of use)
Key secondary outcomes
Improvement in gingivitis and questionnaire responses at each evaluation point (before the plaque-detecting toothbrush experiment and at the follow-up visit after 2-3 weeks of use)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The plaque-detecting toothbrush will be provided to participating parent-child pairs, who will use it at home as part of their routine toothbrushing. The intervention period will last 2-3 weeks, after which evaluations will be conducted at the follow-up visit.
Interventions/Control_2
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parent-child pairs consisting of elementary school children (ages 6-12) attending the dental clinics cooperating in this study and their guardians, who have received an explanation of the study and provided written informed consent.
Key exclusion criteria
Individuals who cannot accept the use of an electric toothbrush; those engaged in the dental profession; those with severe systemic diseases (e.g., cardiac disease, acute illness, abnormal blood pressure, malignancy, febrile illness, infectious disease, hemophilia, diabetes, liver disease, etc.); those who are pregnant or possibly pregnant; those on long-term prescription medications from a hospital; those undergoing orthodontic treatment with wire-based appliances (non-wire types are acceptable); those whose dental crowns or restorations are entirely provided under private treatment; and those using dentures, partial dentures, bridges, or implants.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Aida |
Organization
Institute of SCIENCE TOKYO
Division name
Graduate School of Medical and Dental Sciences Department of Dental Public Health
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5475
aida.j.e32f@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Aida |
Organization
Institute of SCIENCE TOKYO
Division name
Graduate School of Medical and Dental Sciences Department of Dental Public Health
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5475
Homepage URL
aida.j.e32f@m.isct.ac.jp
Sponsor or person
Institute
Institute of SCIENCE TOKYO
Institute
Department
Personal name
Funding Source
Organization
Institute of SCIENCE TOKYO
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
Institute of SCIENCE TOKYO
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5475
aida.j.e32f@m.isct.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
| 2025 | Year | 09 | Month | 11 | 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
| 2025 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067529
