UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041863 |
|---|---|
| Receipt number | R000047791 |
| Scientific Title | Effects of consumption of the test food on the oral cavity environment in healthy subjects: an open-label trial |
| Date of disclosure of the study information | 2020/09/23 |
| Last modified on | 2021/04/01 09:26:09 |
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Basic information
Public title
Effects of consumption of the test food on the oral cavity environment in healthy subjects
Acronym
Effects of consumption of the test food on the oral cavity environment in healthy subjects
Scientific Title
Effects of consumption of the test food on the oral cavity environment in healthy subjects: an open-label trial
Scientific Title:Acronym
Effects of consumption of the test food on the oral cavity environment in healthy subjects
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the oral cavity environment in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The measured values and logarithmic values of Porphyromonas gingivalis (P. gingivalis)
Key secondary outcomes
1. The questionnaires (Likert Scale method)
2. Gingival Index (GI), Plaque Index (PlI), bleeding on probing, depth of periodontal pockets, and progression of dental caries
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take the test food one tablet a day before bedtime for six weeks
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adult subjects
2. Subjects who are judged to be eligible to participate in the study by the physician
3. Subjects who has a high measured value of P. gingivalis at screening (before consumption)
4. Subjects who has a high measured value of GI at screening (before consumption)
Key exclusion criteria
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 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. 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 antibacterial drugs within the last three months before the agreement to participate in this trial
7. allergic to medications and/or the test-food-related products
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 three months
12. have a medical history, current illness, or are suspected to be a Sjogren's syndrome
13. have disorders associated with salivary gland such as dry mouse and salivary stone disease
14. undergoing medical treatment of periodontal disease or dental caries
15. are under treatment or diagnosed with any of dental diseases
16. are smokers, or started smoking cessation within a year before the invitation to participate in this trial
17. are lactating, pregnant, or intending to become pregnant
18. have been enrolled in other clinical trials within the last three months before the invitation to participate in this trial, or plan to participate in another trial during this trial
19. are judged by the principal investigator as ineligible to participate in the trial
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Horiuchi |
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
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
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 or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
DENSO CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Yuseikai, Horiuchi Dental Clinic
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi 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
医療法人社団優正会 堀内歯科医院 (東京都)
Medical Corporation Yuseikai, Horiuchi Dental Clinic (Tokyo, Japan)
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)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 23 | 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
14
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 23 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047791
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| Registered date | File name |
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