UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059766 |
|---|---|
| Receipt number | R000068343 |
| Scientific Title | Exploratory Study on the Cleaning Efficacy of Molded Toothbrushes |
| Date of disclosure of the study information | 2025/11/13 |
| Last modified on | 2025/11/13 16:15:32 |
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Basic information
Public title
Study on the Cleaning Efficacy of Molded Toothbrushes
Acronym
Study on the Cleaning Efficacy of Molded Toothbrushes
Scientific Title
Exploratory Study on the Cleaning Efficacy of Molded Toothbrushes
Scientific Title:Acronym
Study on the Cleaning Efficacy of Molded Toothbrushes
Region
| Japan |
Condition
Condition
dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the cleaning efficacy of molded toothbrushes compared to conventional tufted toothbrushes in adults through a randomized crossover trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness of dental plaque removal during use of toothbrushes
Key secondary outcomes
Relationship between dental plaque accumulation and the subjective feeling of smoothness
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Molded toothbrush
Interventions/Control_2
Tufted toothbrush
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who exhibit at least twenty percent plaque accumulation on the anterior teeth from canine to canine in both the maxilla and the mandible, corresponding to FDI notation thirteen to twenty-three and thirty-three to forty-three.
Subjects who have voluntarily consented to participate in the study.
Key exclusion criteria
Subjects who are wearing orthodontic appliances
Subjects who have any prosthetic restoration on any of the twelve anterior teeth in the maxilla or mandible
Subjects who have lost any of the twelve anterior teeth in the maxilla or mandible
Subjects who have an allergy to plaque disclosing solution or latex
Subjects who are pregnant or may be pregnant
Subjects who smoke
Subjects deemed unsuitable by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Kawaguchi |
Organization
Lion Corporation
Division name
Global Development Center
Zip code
1320035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo 132-0035, Japan
TEL
08023436535
assy@lion.co.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Aoki |
Organization
Lion Corporation
Division name
Global Development Center
Zip code
1320035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo 132-0035, Japan
TEL
08023064144
Homepage URL
yuuko_a@lion.co.jp
Sponsor or person
Institute
Lion Corporation
Institute
Department
Personal name
Funding Source
Organization
Lion Corporation
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
Institutional Review Board of Lion corporation
Address
1-3-28, Kuramae, Taito-ku, Tokyo, Japan
Tel
0367393711
tohki@lion.co.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 | 11 | Month | 13 | 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 | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | 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 | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068343
