UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043083 |
|---|---|
| Receipt number | R000049186 |
| Scientific Title | Cleaning evaluation with OC441 detergent |
| Date of disclosure of the study information | 2021/01/25 |
| Last modified on | 2023/04/25 18:16:47 |
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Basic information
Public title
Cleaning evaluation with detergent
Acronym
Cleaning evaluation with detergent
Scientific Title
Cleaning evaluation with OC441 detergent
Scientific Title:Acronym
Cleaning evaluation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Oral condition of the subject, analysis of debris on their objects and cleaning evaluation with OC441 detergent.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
volume of the debris
biological activity in the debris
Key secondary outcomes
smell score
roughness score
composition analysis of the debris
survey
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Healthy people who go to Tokushima University Hospital by maintenance
-People who wear prosthesis
-Subjects who understand the contents of the test and participate it
Key exclusion criteria
-Subjects with serious wound in the oral cavity
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Tokushima University Graduate School
Division name
Biomedical Sciences
Zip code
770-8504
Address
3-18-15, kuramoto, Tokushima, Tokushima, JAPAN
TEL
+81-88-633-7346
ichi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsunori |
| Middle name | |
| Last name | Sonoi |
Organization
Kao Corporation
Division name
Personal Healthcare Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo, JAPAN
TEL
+81-3-5630-9750
Homepage URL
sonoi.atsunori@kao.com
Sponsor or person
Institute
Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Ethics Committee of the Tokushima University Hospital
Address
2-50-1, kuramoto, Tokushima, Tokushima, JAPAN
Tel
+81-88-633-9294
awachiken@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(徳島県)
Tokushima University Hospital (Tokushima)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 25 | 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
20
Results
The reduction rate of ATP activity on the denture surface due to cleaning was 95.1% in the test group and 95.6% in the control group. ATP activity in both groups decreased significantly, and there was no difference in ATP activity between the two groups. At the clasp, ATP activity decreased significantly in both groups.The denture plaque area measured by fluorescent staining also decreased significantly in both groups, with no difference between the groups.
Results date posted
| 2023 | Year | 04 | Month | 25 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Oral condition of the subject, analysis of debris on their objects and cleaning evaluation with OC441 detergent.
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049186
| 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 |
