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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004090
Receipt No. R000004926
Scientific Title Development of antibacterial tissue conditioner with biology-derived component
Date of disclosure of the study information 2010/08/24
Last modified on 2010/08/24

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Basic information
Public title Development of antibacterial tissue conditioner with biology-derived component
Acronym The anti-microbiological property to C.albicans of the Juncus-mixed tissue conditioners
Scientific Title Development of antibacterial tissue conditioner with biology-derived component
Scientific Title:Acronym The anti-microbiological property to C.albicans of the Juncus-mixed tissue conditioners
Region
Japan

Condition
Condition Denture stomatitis by Candida albicans
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate anti-microbiological property to C.albicans of the Juncus-mixed tissue conditioners.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Morphology of C. albicans on the specimen after 1 week
Assessment of doctor(operability)
Patient satisfaction(taste,smell)
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food Device,equipment
Interventions/Control_1 Specimen that adds the juncus powder of 5mass% for the adjustment patient of the tissue conditioner use in one week.
Interventions/Control_2
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
30 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria When the denture wearer admits the pressure of an excessive mucous membrane with the denture base, and it is judged indications of the tissue conditioner
Key exclusion criteria When there is a proposal of discontinuance from the testee
When it turns out that the testee is not an example of the object syndrome after it begins to research
When an accident happened by accident is caused
When the adverse experience judges that the person in charge of the causing research or the researcher should discontinue it
When it is judged that there is an important deviating from the execution plan and it is not possible to evaluate it
Additionally, when the person in charge of the research or the researcher judges that the continuance of the research is difficult, and discontinuance is appropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihito Naito
Organization Tokushima university hospital
Division name dentistry
Zip code
Address 770-8503, 2-50-1 Kuramoto, Tokushima, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization dentistry
Division name Oral and maxilofacial prosthodontics
Zip code
Address
TEL
Homepage URL
Email yoshi11@dent.tokushima-u.ac.jp

Sponsor
Institute Oral and maxilofacial prosthodontics
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 24 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 Open public recruiting
Date of protocol fixation
2010 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 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
2010 Year 08 Month 24 Day
Last modified on
2010 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004926

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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