UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044864 |
|---|---|
| Receipt number | R000051244 |
| Scientific Title | Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction |
| Date of disclosure of the study information | 2021/07/14 |
| Last modified on | 2021/10/25 12:03:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction
Acronym
Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction
Scientific Title
Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction
Scientific Title:Acronym
Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the efficacy in oral malodorous reduction by applying a specified single dose of a halitosis-preventive mouthwash to the subjects who are aware of bad breath.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of hydrogen sulfide
Key secondary outcomes
1. The number of bacteria in saliva
2. Autoinducer-2 activity
3. Concentration of methyl mercaptan
4. Concentration of dimethyl sulfide
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Mouthwash using the test liquid (10 mL) for 20 sec, without rinsing.
Interventions/Control_2
Mouthwash using the placebo liquid (10 mL) for 20 sec, without rinsing.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females ranging in age from 20 to 64, at the time of informed consent.
(2) Subjects being applicable to at least one of the following criteria:
Subjects with self-recognition of bad breath
Subjects who have been pointed out their bad breath
Subjects who are aware of dry mouth
(3) Subjects with not less than 112 ppb of hydrogen-sulfide concentration in their breath.
(4) Subjects who have received enough explanation about this study and were able to understand that, and to give written informed consent.
Key exclusion criteria
(1) Subjects who are continuously taking medicines that may affect the test results, except applying a nasal spray and eye drops.
(2) Subjects who have any spots with not less than 7 mm of probing pocket depth.
(3) Subjects who are undergoing dental treatment for tooth decay, gingivitis, etc., or ones having tooth decay.
(4) Subjects equipped with partial/full dentures.
(5) Subjects being in the process of straightening their teeth.
(6) Subjects who have any tooth defecting, or coming off.
(7) Subjects having a severe medical history of dry mouth symptom, Sjogren's syndrome, or systemic illness.
(8) Subjects who have previous and/or current medical history of serious diseases (e.g., heart, liver, kidney, digestive organ).
(9) Females who are pregnant, lactating, or possibly pregnant.
(10) Subjects who are taking medicine, foods with functional claims, health foods, and oral care products (mouthwash, etc.) that may affect the improvement of oral function.
(11) Subjects with an extremely irregular dietary habits or lifestyle (e.g. alternative work schedule, graveyard shift).
(12) Subjects who take excessive alcohol.
(13) Subjects who are allergic to drugs or foods.
(14) Subjects who are participating or have been participated to the other clinical tests with some kind of medicine/food within the last 4 weeks before this trial, or planning to join those after giving informed consent.
(15) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinion.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mie |
| Middle name | |
| Last name | Kaneko |
Organization
Chiyoda Oralhealth Care Clinic
Division name
Director
Zip code
101-0061
Address
3F Suidobashi Nishiguchi Kaikan, 2-20-7 Kanda-Misaki-Cho, Chiyoda-ku, Tokyo, Japan
TEL
03-3288-8801
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Fujimoto |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.jp
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
チヨダオーラルヘルスケアクリニック
Chiyoda Oralhealth Care Clinic
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 14 | 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
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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 14 | Day |
Last modified on
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051244
