UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032331 |
|---|---|
| Receipt number | R000036870 |
| Scientific Title | Effect of halitosis suppression by using metal ion-containing preparation |
| Date of disclosure of the study information | 2018/04/20 |
| Last modified on | 2020/10/13 16:40:29 |
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Basic information
Public title
Effect of halitosis suppression by using metal ion-containing preparation
Acronym
Effect of halitosis by using ion-containing preparation
Scientific Title
Effect of halitosis suppression by using metal ion-containing preparation
Scientific Title:Acronym
Effect of halitosis by using ion-containing preparation
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of suppressing halitosis in ion-containing preparations is clarified.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of oral malodor Volatile sulfur compounds
Measurement of oral bacteria
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Metal ion-containing mouth rinse
Interventions/Control_2
Metal ion-containing vtoothpaste
Interventions/Control_3
placebo
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
Dentist and university who obtained with informed consent of this study
Key exclusion criteria
Smoker
Those who did not agree to participate in the research
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Soh |
| Middle name | |
| Last name | Sato |
Organization
The Nippon Dental University
School of Life Dentistry at Niigata
Division name
Department of Periodontology
Zip code
951-8580
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
025-267-1500
s-sato@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Morozumi |
Organization
The Nippon Dental University
Division name
Department of Periodontology
Zip code
951-8580
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
025-267-1500
Homepage URL
hiroki@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University
School of Life Dentistry at Niigata
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
The Nippon Dental University School of Life Dentistry at Niigata
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
Tel
025-267-1500
shinkai@ngt.ndu.ac.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
| 2018 | Year | 04 | Month | 20 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 20 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036870
