Unique ID issued by UMIN | UMIN000045810 |
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Receipt number | R000052297 |
Scientific Title | Effects of consumption of the test food on the oral environment in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2023/02/24 |
Last modified on | 2022/11/02 17:44:24 |
Effects of consumption of the test food on the oral environment in healthy subjects
Effects of consumption of the test food on the oral environment in healthy subjects
Effects of consumption of the test food on the oral environment in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on the oral environment in healthy subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effect of consumption of the test food on the oral environment in healthy Japanese subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
The gingival index (GI)
1. The number of periodontosis-related bacteria
2. The evaluation of periodontosis
3. The number of dental caries-related bacteria
4. Halitosis
5. Questionnaire
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Food |
Take test food once a day for 4 weeks
Take placebo food once a day for 4 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Male or female
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects who have P. gingivalis at Scr
7. Subjects who have relatively high GI level at Scr
Subjects who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
5. are currently taking medications (including herbal medicines) and supplements
6. have used antibiotics within the preceding three months before the agreement to participate in this trial
7. are allergic to medicines and/or food
8. regularly use gargle medicine
9. use artificial tooth, post crowns, dentures, implants or bridges
10. use floss, interdental brushes, and mouthwash at brushing their teeth
11. have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last three months before the agreement to participate in this trial
12. are being treated, have a past medical history, or are suspected of having Sjogren's syndrome
13. suffer from disorders associated with salivary gland such as dry mouse and salivary stone disease
14. are being treated periodontosis or dental caries
15. are being treated or are diagnosed with any of dental diseases
16. are smokers, or started smoking cessation within one year before the agreement to participate in this trial
17. are pregnant, breast-feeding, and planning to become pregnant
18. suffer from COVID-19
19. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
20. are judged as ineligible to participate in the study by the physician
20
1st name | Masahiko |
Middle name | |
Last name | Horiuchi |
Medical Corporation Yuseikai, Horiuchi Dental Clinic
Director
141-0022
2F AM Bldg., 2-3-3, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-3449-1033
dr_horiuchi@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.
S&B FOODS INC.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Medical Corporation Yuseikai, Horiuchi Dental 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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
医療法人社団優正会 堀内歯科医院 (東京都)
Medical Corporation Yuseikai, Horiuchi Dental Clinic (Tokyo, Japan)
2023 | Year | 02 | Month | 24 | Day |
Unpublished
22
Completed
2021 | Year | 10 | Month | 13 | Day |
2021 | Year | 10 | Month | 13 | Day |
2021 | Year | 10 | Month | 22 | Day |
2022 | Year | 02 | Month | 27 | Day |
2021 | Year | 10 | Month | 20 | Day |
2022 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052297
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