UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051611 |
|---|---|
| Receipt number | R000058890 |
| Scientific Title | Utility confirmation study on the oral effects of consecutive use of dentifrice NW372 |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/11/13 15:45:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy test of the dentifrice
Acronym
Efficacy test of the dentifrice
Scientific Title
Utility confirmation study on the oral effects of consecutive use of dentifrice NW372
Scientific Title:Acronym
Efficacy test of the dentifrice
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the oral benefits of continuous use of dentifrice NW372.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of gingival condition before and after 4 weeks of dentifrice use
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use dentifrice NW372 at least twice a day for 4 weeks
Interventions/Control_2
Use control dentifrice at least twice a day for 4 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
| 30 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Male of 30 to 49 years of age.
2.Subjects who brush their teeth at least twice a day.
3.Subjects who agreed to use only the test dentifrice and designated toothbrush during the study period.
Key exclusion criteria
1.Subjects with implants, dentures, or false teeth in the anterior maxillary region.
2.Subjects with full denture.
3.Smokers.
4.Subjects who are currently attend a dental clinic.
5.Subjects who are already participating in other research at the time of receiving an explanation of the research, or who are scheduled to participate in other research during the period of cooperation for participation in this study.
6.Subjects who are judged by the principal investigator to be inappropriate to participate in the research due to other reasons such as noncompliance with compliance obligations.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Nakatsu |
Organization
Kao Corporation
Division name
Personal health care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9747
nakatsu.susumu@kao.com
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Chiba |
Organization
Kao Corporation
Division name
Personal health care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9747
Homepage URL
chiba.atsuko@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 | 08 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 20 | 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 | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058890
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
