UMIN-CTR Clinical Trial

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
Email	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
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051244