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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032331
Receipt No. 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

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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
Email 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
Email hiroki@ngt.ndu.ac.jp

Sponsor
Institute The Nippon Dental University
School of Life Dentistry at Niigata
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 The Nippon Dental University School of Life Dentistry at Niigata
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
Tel 025-267-1500
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036870

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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