UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049663 |
|---|---|
| Receipt number | R000056557 |
| Scientific Title | A study to verify the halitosis improvement and oral rinsing effects: an open-label trial |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/04/19 12:27:38 |
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Basic information
Public title
A study to verify the halitosis improvement and oral rinsing effects
Acronym
A study to verify the halitosis improvement and oral rinsing effects
Scientific Title
A study to verify the halitosis improvement and oral rinsing effects: an open-label trial
Scientific Title:Acronym
A study to verify the halitosis improvement and oral rinsing effects
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 halitosis improvement and oral rinsing effects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. B/B value
Key secondary outcomes
1. Amount of adenosine triphosphate (ATP) in saliva
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
| Other |
Interventions/Control_1
Duration: Four weeks
Test product: Mouthwash (containing 0.005% hypochlorous acid)
Administration:
On the day of screening (before using test product; Scr), after each pre-use measurement, rinse your mouth with approximately 20 ml of test product for approximately 20 seconds and spit it out. After that, receive each measurement again.
After the start of use, use test product in the same manner as above after brush teeth following each meal. Use it three times daily.
*When using the test product, be careful to rinse the entire mouthful of the test product, not just a portion of it.
*The test product should not be swallowed, and must be spit out after rinsing.
*If you forget to use the test product, use it as soon as you remember. Daily amounts should be used within the day and not carried over to the next day.
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
| 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 will be selected based on the results of halitosis measurement at Scr
Key exclusion criteria
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. are currently undergoing treatment for any of the following chronic diseases: 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," or "Foods with Functional Claims" in daily
5. are currently taking medications (including herbal medicines) and supplements
6. are allergic to medicines and/or the test food related products
7. show allergic reactions to hypochlorous acid
8. are pregnant, lactating, or planning to become pregnant during this trial
9. suffer from COVID-19
10. 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
11. are judged as ineligible to participate in this study by the physician
12. take functional food/beverage to improve halitosis
13. use artificial tooth, post crowns, dentures, implants or bridges
14. regularly use gargle medicine, medicated toothpaste, floss, interdental brush, and mouthwash
15. have a medical history or current history of Sjogren's syndrome, or who are suspected it
16. have diseases associated with salivary gland such as dry mouse and salivary stone disease
17. are undergoing medical treatment for periodontosis or dental caries
18. are dental treatment or have dental diseases
19. are smokers, or started smoking cessation within one year before the agreement to participate in this trial
20. plan to receive dental maintenance care (such as removing dental plaque) at the dental clinic during this trial
21. are more likely to get stomatitis
22. cannot brush their teeth three times a day
Target sample size
10
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
Local Power Co.,Ltd.
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 | 12 | Month | 01 | 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
11
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 | 11 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 12 | 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 | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056557
