UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049704 |
|---|---|
| Receipt number | R000056616 |
| Scientific Title | Ingestion test of the oral composition |
| Date of disclosure of the study information | 2022/12/09 |
| Last modified on | 2022/12/06 14:52:30 |
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Basic information
Public title
Efficacy test of the oral composition
Acronym
Efficacy test of the oral composition
Scientific Title
Ingestion test of the oral composition
Scientific Title:Acronym
Efficacy test of the oral composition
Region
| Japan |
Condition
Condition
Gingivitis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy for oral condition of the oral composition T0210(code).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Gingival condition before and after 8wks application
Key secondary outcomes
Ratio of specific bacteria in plaque
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
| Food |
Interventions/Control_1
Ingest T0210 three times a day for 8wks.
Interventions/Control_2
Ingest placebo three times a day for 8wks.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 20-65
2. Those who have gingival inflammation that falls under any of the following A, B, or C
A. When brushing your teeth, the gums may bleed.
B. Gingiva may swell
C. At dental offices and dental checkups, it has been pointed out that the gums are swollen and the periodontal pockets are deep.
Key exclusion criteria
(1) Those suffering from systemic diseases (diabetes, heart disease, kidney disease, liver disease, congenital heart disease, etc.)
(2) Those who are taking drugs to improve glucose metabolism and lipid metabolism, or antihypertensive drugs
(3) Those who plan to consume foods for specified health uses, foods with function claims, and dietary supplements (supplement foods such as capsules) that are considered to affect this study during the study period (which appeal to triglycerides, blood sugar, blood pressure, cholesterol, and body fat)
(4) Those who have obvious trauma in the oral cavity
(5) Those who are visiting a medical institution due to severe periodontal disease or oral disease
(6) Those who have been prescribed antibiotics at a dental clinic due to gingival swelling within one year
(7) Those who have had fever or respiratory symptoms in themselves or a family member living with them from one week before the measurement date, or those who have been in close contact with a person infected with the covid-19.
(8) Those who use mouthwash on a daily basis (e.g., isodine mouthwash, clean mouthwash, gargle fresh, etc.)
(9) Those who have collected 200 mL or more of blood (blood donation, etc.) within one month of the start of this study or 400 mL within three months.
(10) Those who have severe anemia in the most recent medical examination
(11) Those who have experienced side effects (feeling sick, dizziness, nausea, collapse, etc.) after blood collection
(12) Those who have been allergic to sugar alcohols such as xylitol and erythritol in the past
(13) Those who, for other reasons, are judged to be ineligible for the test by the dentist in charge of the trial or the director of the test and research.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Nakatsu |
Organization
Kao Corporation
Division name
Personal Health Care Products 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 | Teppei |
| Middle name | |
| Last name | Tajikara |
Organization
Kao Corporation
Division name
Personal Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9747
Homepage URL
tajikara.teppei@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
| 2022 | Year | 12 | Month | 09 | 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
| 2022 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 11 | 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
| 2022 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056616
