UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042257 |
|---|---|
| Receipt number | R000048250 |
| Scientific Title | Validation study about halitosis-reducing effects by long-term usage of zinc chloride-containing toothpaste and copper gluconate-containing mouth-rinse solution |
| Date of disclosure of the study information | 2021/09/21 |
| Last modified on | 2021/07/27 10:31:04 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048250
