UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048609 |
|---|---|
| Receipt number | 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 | 2024/04/12 09:13:49 |
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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
| 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 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
| Food |
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.
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.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
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
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
Target sample size
30
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
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
| 2022 | Year | 08 | Month | 05 | 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
34
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
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 10 | 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 | 08 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055379
