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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000048609 |
Receipt No. | R000055379 |
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 | 2022/08/05 |
Last modified on | 2022/08/05 |
Basic information | ||
Public title | Effects of consumption of the test food on the oral environment in healthy subjects | |
Acronym | Effects of consumption of the test food on the oral environment in healthy subjects | |
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 | |
Scientific Title:Acronym | Effects of consumption of the test food on the oral environment in healthy subjects | |
Region |
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Condition | |||
Condition | Healthy Japanese subjects | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the effect of consumption of the test food on the oral environment in healthy Japanese subjects |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1. The measurement value of halitosis {brilliant breath (B/B) value in B/B checker} |
Key secondary outcomes | 1. Subjective symptom measured by visual analogue scale (an original questionnaire)
2. The volume of saliva |
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 | Institution is not considered as adjustment factor. |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Duration: Two weeks
Test food: Lactic acid bacteria and yeast-chewable tablet (yogurt flavor) Administration: Take one tablet twice per day within 3-5 minutes (as long as possible) without chewing right after each toothbrushing in the morning and evening *If you forget to lick the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. |
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Interventions/Control_2 | Duration: Two weeks
Test food: Placebo chewable tablet Administration: Take one tablet twice per day within 3-5 minutes (as long as possible) without chewing right after each toothbrushing in the morning and evening *If you forget to lick the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Japanese
2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who are concerned about their halitosis 6. Subjects who are concerned about their oral sticky 7. Subjects who are concerned about their oral dryness 8. Subjects whose measurement value of halitosis is relatively high |
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Key exclusion criteria | 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who 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. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who 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 10. Subjects who are judged as ineligible to participate in this study by the physician 11. Subjects who use artificial tooth, post crowns, dentures, implants or bridges 12. Subjects who regularly use gargle medicine or mouthwash 13. Subjects who have a medical history or current history of Sjogren's syndrome, or who are suspected it 14. Subjects who have diseases associated with salivary gland such as dry mouse and salivary stone disease 15. Subjects who are undergoing medical treatment for periodontosis or dental caries 16. Subjects who are dental treatment or have dental diseases 17. Subjects who are smokers, or started smoking cessation within one year before the agreement to participate in this trial |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Medical Corporation Yuseikai, Horiuchi Dental Clinic | ||||||
Division name | Director | ||||||
Zip code | 141-0022 | ||||||
Address | 2F AM Bldg., 2-3-3, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan | ||||||
TEL | 03-3449-1033 | ||||||
dr_horiuchi@orthomedico.jp |
Public contact | |||||||
Name of contact person |
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Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | 112-0002 | ||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan. | ||||||
TEL | 03-3818-0610 | ||||||
Homepage URL | |||||||
nao@orthomedico.jp |
Sponsor | |
Institute | ORTHOMEDICO Inc. |
Institute | |
Department |
Funding Source | |
Organization | Maikon no kohara Corporation. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic Medical Corporation Yuseikai, Horiuchi Dental Clinic |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | the ethical committee of the Takara Clinic, Medical Corporation Seishinkai |
Address | 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan. |
Tel | 03-5793-3623 |
IRB@takara-clinic.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 | 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) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055379 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |