UMIN-CTR Clinical Trial

Basic information
Public title	Validation study about halitosis-reducing effects by long-term usage of zinc chloride-containing toothpaste and copper gluconate-containing mouth-rinse solution
Acronym	Validation study about halitosis-reducing effects by long-term usage of zinc chloride-containing toothpaste and copper gluconate-containing mouth-rinse solution
Scientific Title	Validation study about halitosis-reducing effects by long-term usage of zinc chloride-containing toothpaste and copper gluconate-containing mouth-rinse solution
Scientific Title:Acronym	Validation study about halitosis-reducing effects by long-term usage of zinc chloride-containing toothpaste and copper gluconate-containing mouth-rinse solution
Region	Japan

Condition
Condition	Healthy male adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify halitosis-reducing effects by test-product usage for 4 weeks
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concentrations of volatile sulfur compounds, such as H2S, Me3SH and Me2S
Key secondary outcomes	1. Gingivitis index 2. Swelling 3. Reddening 4. Overall effectiveness 5. Tongue coating

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Continuous application of the toothpaste to the subjects, three times a day (after every meal) for 4 weeks.
Interventions/Control_2	Continuous application of the mouth-wash solution to the subjects, three times a day (after every meal) for 4 weeks.
Interventions/Control_3	Continuous application of both the toothpaste and the solution to the subjects, three times a day (after every meal) for 4 weeks.
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	50 years-old >
Gender	Male
Key inclusion criteria	(1) Healthy male subjects ranging in age from 20 to 49 years old. (2) Subjects equipped with not less than 20 teeth, and without some kind of periodontal disease. (3) Subjects having mild-to-moderate gingivitis. (4) Subjects with bad breath at steady state. (5) Subjects having meals three times a day, and toothbrushing after each meal. (6) Subjects having not less than four teeth among measurable six teeth (FDI: 16, 21, 24, 36, 41, 44), or their alternatives (FDI: 17, 15, 11, 22, 25, 37, 35, 31, 42, 45). (7) Subjects who gave informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) At the screening test, subjects who were determined as a patient having some dental caries (over C3 level) and/or severe periodontal disease. (2) Subjects with medical treatment for diabetic, chronic kidney, digestive, lung or cancer diseases. (3) Subjects having need of some kind of scaling with oral surgery treatment and/or anesthesia. (4) Subjects with some kind of allergy. (5) Subjects equipped with removable denture. (6) Subjects with smoking habit. (7) Subjects who are now under the other clinical trials with some kind of medicine/food, or going to take part in those trials. (8) Subjects who have took in some kind of antibiotic and/or antibacterial agent, regularly or within the last month to the screening test. (9) All through this trial, subjects who have any difficulty in refraining from using some kind of mouth-rinse solution and/or interdental brush. (10) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomohiko Middle name Last name Yamaguchi
Organization	DAIICHI SANKYO HEALTHCARE CO.,LTD
Division name	Chief Director
Zip code	140-8710
Address	3-14-10 Nihonbashi, Chuo-ku, Tokyo 140-8710, Japan
TEL	03-5225-6330
Email	yamaguchi.tomohiko.m6@daiichisankyo-hc.co.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	7F Shibaura-Omodaka Building, 1-9-7 Shibaura, Minato-ku, Tokyo 105-0023, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	DAIICHI SANKYO HEALTHCARE 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	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Building, 13-4-201 Nihonbashi-Kodenma-Cho, Chuo-ku, Tokyo 103-0001, Japan
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.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

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 21 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	Completed
Date of protocol fixation	2020 Year 09 Month 04 Day
Date of IRB	2020 Year 08 Month 06 Day
Anticipated trial start date	2020 Year 09 Month 21 Day
Last follow-up date	2020 Year 11 Month 29 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 10 Month 27 Day
Last modified on	2021 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048250