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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013162
Receipt No. R000015347
Scientific Title Change of oral microbial composition by zinc ion
Date of disclosure of the study information 2014/02/14
Last modified on 2014/02/14

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Basic information
Public title Change of oral microbial composition by zinc ion
Acronym Change of oral microbiota by zinc ion
Scientific Title Change of oral microbial composition by zinc ion
Scientific Title:Acronym Change of oral microbiota by zinc ion
Region
Japan

Condition
Condition periodontitis, halitosis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Change of microbial composition by washing mouth with the solution containing zinc ion is evaluated. Next, change of microbial composition is analyzed after stopping mouth rinsing in the solution containing zinc ion. Moreover, the stability of human oral microbiota is evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of oral microbial composition
Key secondary outcomes

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 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Washing mouth by 0.3% zinc chloride solution is continued for 8 weeks.
Interventions/Control_2 Washing mouth by 0.3% zinc chloride solution is continued for 4 weeks and subsequently washing mouth is continued by 0.9% saline solution for 4 weeks.
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
19 years-old <=
Age-upper limit
22 years-old >=
Gender Female
Key inclusion criteria volunteers without systemic diseases
Key exclusion criteria Under dental treatment
Antimicrobial drug administration in the past 3 mouths
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nao Taniguchi
Organization Fukuoka Dental College
Division name Department of General Dentistry
Zip code
Address 2-15-1, Tamura, Sawara-ku, Fukuoka
TEL 81-92-801-0411
Email naojsz@college.fdcnet.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nao Taniguchi
Organization Fukuoka Dental College
Division name Department of General Dentistry
Zip code
Address 2-15-1, Tamura, Sawara-ku, Fukuoka
TEL 81-92-801-0411
Homepage URL
Email naojsz@college.fdcnet.ac.jp

Sponsor
Institute Fukuoka Dental College
Institute
Department

Funding Source
Organization Fukuoka Dental College
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福岡歯科大学

Other administrative information
Date of disclosure of the study information
2014 Year 02 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 Completed
Date of protocol fixation
2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 14 Day
Last modified on
2014 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015347

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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