UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004090 |
|---|---|
| Receipt number | 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 10:35:12 |
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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
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
yoshi11@dent.tokushima-u.ac.jp
Sponsor or person
Institute
Oral and maxilofacial prosthodontics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004926
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
