UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050922 |
|---|---|
| Receipt number | R000058045 |
| Scientific Title | Investigation test of the mechanism of oral cavity of 202302[g2023001] |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/04/25 14:12:37 |
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Basic information
Public title
Use test of mouthwash
Acronym
Use test of mouthwash
Scientific Title
Investigation test of the mechanism of oral cavity of 202302[g2023001]
Scientific Title:Acronym
Investigation test of the mechanism of 202302
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate of the mechanism of oral cavity of 202302.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Components of gingival crevicular fluid.
Evaluations are taken 5 times, before starting test, after using mouthwash for 1 days and 7 days, and 4 weeks, and 8 weeks.
Key secondary outcomes
Measurement of oral index. Measurements are taken 3 times, before starting test, after using mouthwash for 4 weeks and 8 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rinsing oral cavity with 202302 for 30 seconds 3 times a day for 8 weeks.
Interventions/Control_2
Rinsing oral cavity with placebo for 30 seconds 3 times a day for 8 weeks.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male or female of 20 to 69 years of age
2.1aor2aor3a
1a.Subjects who may bleed from gingival.
2a.Subjects with occasional swelling of gingival.
3a.Subjects have been diagnosed with swollen gingival or deep periodontal pockets.
3.Subjects who have 20 or more of their own teeth.
Key exclusion criteria
1.Subjects with systemic illness.
2.Subjects who are taking prescription medicine (except for anti-hay fever).
3.Subjects with a disease in the oral cavity and are consulting the medical institution.
4.Subjects undergoing treatment for periodontal disease
5.Subjects undergoing orthodontic therapy.
6.Subjects with mobile tooth.
7.Subjects with an implant
8.Subjects who have regular dental checkups at least 3 times a year.
9.The pregnant and subjects who hope to get pregnant during the exam period.
10.Subjects with smoking habit.
11.Subjects who participate in the other examinations.
12.Subjects from outside the company who work in an advertising agency, an investigation, consultancy, mass communication, and the manufacturing industry of health food, cosmetics, toiletries, a sanitary items, and a distributive trade.
13.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 | Koichi |
| Middle name | |
| Last name | Misawa |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
misawa.koichi@kao.com
Public contact
Name of contact person
| 1st name | Hatsumi |
| Middle name | |
| Last name | Souno |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-Machi, Haga-Gun Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7236
Homepage URL
souno.hatsumi@kao.com
Sponsor or person
Institute
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
| 2023 | Year | 05 | Month | 15 | 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
| 2023 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | 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
| 2023 | Year | 04 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058045
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| Registered date | File name |
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