Unique ID issued by UMIN | UMIN000041594 |
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Receipt number | R000047482 |
Scientific Title | Effects of consumption of the test food on the oral cavity environment in healthy subjects: A randomized, double-blind, placebo-controlled, parallel-group comparison study |
Date of disclosure of the study information | 2020/08/28 |
Last modified on | 2021/11/02 09:45:10 |
Effects of consumption of the test food on the oral cavity environment in healthy subjects
Effects of consumption of the test food on the oral cavity environment in healthy subjects
Effects of consumption of the test food on the oral cavity environment in healthy subjects: A randomized, double-blind, placebo-controlled, parallel-group comparison study
Effects of consumption of the test food on the oral cavity environment in healthy subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on the oral cavity environment in healthy subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
The number of periodontosis-related bacteria
1. The number of periodontosis-related bacteria
2. Assessment of periodontosis
3. The number of dental caries-related bacteria
4. Halitosis
5. Oral moisture values
6. The volume of saliva
7. Salivary pH
8. Serum high-sensitivity CRP concentration
9. Salivary IgA
10. Original questionnaires
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Food |
Duration: Four weeks
Test food: Active chewable tablet
Administration:
Examination at the start of the test-food consumption: To suck three tablets without chewing after the examination.
Between the day after the examination at the start of the test-food consumption and the day before the examination at four weeks after the start of the test-food consumption: To suck three tablets without chewing once a day at any time during the day
*If you forget to take the test food, take it as soon as you remember within the day.
Duration: Four weeks
Test food: Placebo
Administration:
Examination at the start of the test-food consumption: To suck three tablets without chewing after the examination
Between the day after the examination at the start of the test-food consumption and the day before the examination at four weeks after the start of the test-food consumption: To suck three tablets without chewing once a day at any time during the day
*If you forget to take the test food, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adult subjects
2. Subjects who are judged as healthy and eligible to participate in the study by the physician
3. Subjects who have a relatively large number of periodontosis-related bacteria at screening (before consumption)
Subjects who
1.undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
2.have a pacemaker or an implantable cardioverter defibrillator (ICD)
3.undergoing treatment for cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4.use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily
5.currently taking medicines (include herbal medicines) and supplements
6.have used meperidine, hydrocodone, morphine, oxycontin, clonazepam, lorazepam, phenobarbital, or zolpidem
7.have used antibacterial drugs within the last 3 months before the invitation to participate in this trial
8.regularly use gargle medicine
9.use artificial tooth, post crowns, dentures, or implants
10.regularly use floss, interdental cleaner, and mouthwash
11.have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last 3 months
12.have a medical history, current illness, or are suspected to be a Sjogren's syndrome
13.suffer from disorders associated with salivary gland such as dry mouse and salivary stone disease
14.whose salivary secretion volume at rest is less than 1.5 g/15 min
15.are under treatment of periodontosis or dental caries
16.undergoing treatment or diagnosed with any of dental diseases
17.are smokers, or started smoking cessation within a year before the invitation to participate in this trial
18.allergic to medications and/or the test food-related products
19.are lactating, pregnant, or intending to become pregnant
20.have been enrolled in other clinical trials within the last 3 months before the invitation to participate in this trial, or plan to participate in another trial during this trial
21.are judged by the principal investigator as ineligible to participate in the trial
40
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | Naoko |
Middle name | |
Last name | SUZUKI |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
TOKIWA PHYTOCHEMICAL Co., Ltd.
Profit organization
Medical Corporation Yuseikai, Horiuchi Dental Clinic
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
2020 | Year | 08 | Month | 28 | Day |
Unpublished
44
Completed
2020 | Year | 08 | Month | 21 | Day |
2020 | Year | 08 | Month | 21 | Day |
2020 | Year | 08 | Month | 27 | Day |
2020 | Year | 12 | Month | 25 | Day |
2020 | Year | 08 | Month | 28 | Day |
2021 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047482
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