UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058854 |
|---|---|
| Receipt number | R000067306 |
| Scientific Title | A Study on the Handling Methods of Sponge Brushes Using Biomechanical Evaluation |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/08/21 08:19:20 |
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Basic information
Public title
A Study on the Manipulation Method of Sponge Brushes
Acronym
the Manipulation Method of Sponge Brushes
Scientific Title
A Study on the Handling Methods of Sponge Brushes Using Biomechanical Evaluation
Scientific Title:Acronym
the Manipulation Method of Sponge Brushes
Region
| Japan |
Condition
Condition
Oral Hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
From a biomechanical perspective, this study aims to establish indicators for the appropriate use of sponge brushes and to propose effective methods of operation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
applied force during operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Oral care is provided to a simulated patient.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Practitioners who actually provide oral care in caregiving or nursing settings, as well as dental professionals.
Key exclusion criteria
Those who habitually perform improper sponge-brush oral care, or whose simulated patients reported pain or discomfort.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeyoshi |
| Middle name | |
| Last name | KOSEKI |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Preventive Dentistry, Department of Community Social Dentistry
Zip code
980-8575
Address
4-1, Seiryo-cho, Aoba-ku, Sendai, MIyagi
TEL
0227178326
takeyoshi.koseki.b6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takeyoshi |
| Middle name | |
| Last name | KOSEKI |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Preventive Dentistry, Department of Community Social Dentistry
Zip code
980-8575
Address
4-1, Seiryo-cho, Aoba-ku, Sendai, MIyagi
TEL
0227178326
Homepage URL
takeyoshi.koseki.b6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tohoku University Graduate School of Dentistry
Address
4-1, Seiryo-cho, Aoba-ku, Sendai, MIyagi
Tel
022-717-8244
ec_den@rinri.hosp.tohoku.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 | 10 | Month | 01 | 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 | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | 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 | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067306
