UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044482 |
|---|---|
| Receipt number | R000050819 |
| Scientific Title | Evaluation test of composition 210515 for oral cavity |
| Date of disclosure of the study information | 2021/06/11 |
| Last modified on | 2021/06/09 17:15:26 |
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Basic information
Public title
Evaluation test for oral cavity
Acronym
Evaluation test for oral cavity
Scientific Title
Evaluation test of composition 210515 for oral cavity
Scientific Title:Acronym
Evaluation test for oral cavity
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of composition 210515 for oral cavity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of oral index. Measurements are taken 3 times, before starting test, after using composion 210515 for 12 weeks and 24 weeks.
Key secondary outcomes
Taking photography of oral cavity and questionnaire. Each measurement are taken 3 times, before starting test, after using composite210515 for 12 weeks and 24 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
Brushing teeth with oral composition 210515 for 24 weeks.
Interventions/Control_2
Brushing teeth with placebo composition for 24 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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Male or female of 40 to 69 years of age
-Subjects who can come to the test site by their own
-Subjects who can sign by their own will
-1or2, and 3or4or5
1.Subjects who feel that their gums are falling and their teeth are getting longer.
2.Subjects who feel that food gets stuck between their teeth.
3.Subjects who may bleed from gingival.
4.gingival.
5.Subjects have been diagnosed with swollen gingival or deep periodontal pockets.
-Subjects who have 20 or more of their own teeth.
Key exclusion criteria
-Subjects with systemic illness.
-Subjects with a disease in the oral cavity and are consulting the medical institution.
-Subjects with periodontal disease is treated.
-Subjects with the orthodontic therapy.
-Subjects with mobile tooth.
-Subjects with an implant.
-Subjects who have regular dental checkups at least three times a year.
-Subjects who have been prescribed antibiotics for swollen gingival within a year.
-The pregnant and subjects who hope to get pregnant during the exam period.
-Subjects who are taking prescription medicine (except for anti-hay fever).
-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.
-Subjects who participate in the other examinations.
-Subjects who had health problems (fever, cold-like symptom, abnormal taste or smell, etc.) within 2 weeks prior to the test,
or subjects who had a family member living with them who showed abnormalities.
-Subjects who had close contact with COVID-19 infected individuals within 2 weeks prior to the study.
-Subjects who are confirmed positive in the COVID-19 antigen test on the day of measurement.
-Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | hidefumi |
| Middle name | |
| Last name | kitazawa |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-70-3296-8218
kitazawa.hidefumi@kao.com
Public contact
Name of contact person
| 1st name | Hatsumi |
| Middle name | |
| Last name | Souno |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-70-4356-2759
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 Reserach Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 11 | 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
| 2021 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 09 | Day |
Last modified on
| 2021 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050819
