UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049819 |
|---|---|
| Receipt number | R000056552 |
| Scientific Title | Effect of the toothbrush with branched filament ends on dental plaque: A randomized cross-over study |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/06/20 12:54:35 |
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Basic information
Public title
Effect of the toothbrush with branched filament ends on dental plaque: A randomized cross-over study
Acronym
Effect of the toothbrush with branched filament ends on dental plaque
Scientific Title
Effect of the toothbrush with branched filament ends on dental plaque: A randomized cross-over study
Scientific Title:Acronym
Effect of the toothbrush with branched filament ends on dental plaque
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the removal effect of the toothbrush with branched filament ends on dental plaque in patients with periodontal disease when compared to the effect of toothbrush with super tapered filament by a randomized cross-over study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Removal effect on dental plaque when using a toothbrush
Key secondary outcomes
Evaluation of gingival abrasion when using a toothbrush
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Toothbrush with branched filament ends
Interventions/Control_2
Toothbrush with super tapered filament
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with 20 or more present teeth
Key exclusion criteria
Subjects who are missing all molars
Subjects with dental caries or who are undergoing treatment of dental caries
Subjects who are allergic to the components of the dental plaque stain
Subjects who have more than half of teeth with wearing full or 3/4 crowns
Subjects who are judged unsuitable by the examiner
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Hinode |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Hygiene and Oral Health Science
Zip code
770-8504
Address
18-15 Kuramotocho 3-chome, Tokushima
TEL
088-633-7543
hinode@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hinode |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Hygiene and Oral Health Science
Zip code
770-8504
Address
18-15 Kuramotocho 3-chome, Tokushima city
TEL
088-633-7543
Homepage URL
hinode@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Hygiene and Oral Health Science, Tokushima University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc, Oralcare Innovation Dep.
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
Tokushima University Hospital
Address
50-1 Kuramotocho 2-chome, Tokushima
Tel
088-633-7543
hinode@tokushima-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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | 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
52
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056552
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
