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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035554
Receipt No. R000040506
Scientific Title Evaluation of the change of bacterial flora on the surface of prosthetic device by MPC polymer(PMBPAz)
Date of disclosure of the study information 2019/01/15
Last modified on 2019/01/15

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Basic information
Public title Evaluation of the change of bacterial flora on the surface of prosthetic device by MPC polymer(PMBPAz)
Acronym Change the bacterial flora in denture plaque by MPC polymer(PMBPAz)
Scientific Title Evaluation of the change of bacterial flora on the surface of prosthetic device by MPC polymer(PMBPAz)
Scientific Title:Acronym Change the bacterial flora in denture plaque by MPC polymer(PMBPAz)
Region
Japan

Condition
Condition Maxillary edentulous
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the types of bacteria contained in the denture plaque and to clarify the tendency of the bacterial flora.
Basic objectives2 Others
Basic objectives -Others To compare and evaluate how bacteria within the denture plaque will change before and after MPC (PMBPAz)coating.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes the bacterial flora in denture plaque before and after MPC (PMBPAz)coating
Key secondary outcomes Changes the number of bacteria in denture plaque before and after MPC(PMBPAz) coating

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Denture surface was treated with MPC(PMBPAz). Patients used the denture for 1 week. During this period, only use of denture cleaner is restricted. Later 1 week, collect plaques from the dentures and analyze the bacterial flora using the next generation sequencer.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Showa University Dental Hospital Patient who is in the hospital for prosthetic dentistry / implant center
Patients who aged 20 years or older at the time of informed consent.
Patient wearing maxillary complete denture by informed consent.
Patients who got consent from the person concerned about participation in this study.
Key exclusion criteria Patients who have a history of allergy or allergy to the organic compounds contained in MPC.
Patient judged inappropriate at the discretion of the research doctor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuminori Iwasa
Organization Showa University
Division name Department of Prosthodontics
Zip code
Address 2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL 0337871151
Email akituka32@dent.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Tsukahara
Organization Showa University
Division name Department of Prosthodontics
Zip code
Address 2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL 0337871151
Homepage URL
Email akituka32@dent.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization self-funded
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
2019 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 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
2019 Year 01 Month 15 Day
Last modified on
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040506

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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