UMIN-CTR Clinical Trial

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 Fuminori Middle name Last name Iwasa
Organization	Showa University
Division name	Department of Prosthodontics
Zip code	145-8515
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 Akihiro Middle name Last name Tsukahara
Organization	Showa University
Division name	Department of Prosthodontics
Zip code	145-8515
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	Showa univercity Institutional Review Board
Address	2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
Tel	0337871151
Email	akituka32@dent.showa-u.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	2019 Year 01 Month 15 Day

Related information
URL releasing protocol	https://www.biomedres.info/biomedical-research/2methacryloyloxyethyl-phosphorylcholine-polymer-can-f
Publication of results	Published

Result
URL related to results and publications	https://www.biomedres.info/biomedical-research/2methacryloyloxyethyl-phosphorylcholine-polymer-can-f
Number of participants that the trial has enrolled	10
Results	According to this study, the bacterial flora in the denture plaque attached to the maxillary denture is dominated by Firmicutes (84%), followed by Proteobacteria (6.1%), Bacteroidetes (5.2%), and Actinobacteria (Actinobacteria). 1.9%). In addition, the Shannon index was 1.68 and 1.74, and the BC index was 0.14. This result suggests that PMBPAz coating can reduce the amount of denture plaque and does not change the bacterial layer in the plaque.
Results date posted	2021 Year 08 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	A total of 10 men and women participated in this study. The male-female ratio is 7 males and 3 females. The average age was 74.7 years.
Participant flow	In this study, participants will participate in the study for a total of 2 weeks. In the control group, the denture is mechanically and chemically cleaned, then the denture is used for 1 week, and the denture plaque is collected after 1 week. The sample group mechanically and chemically cleans the denture, and then collects the denture plaque one week after coating with PMBPAz. Participants shall perform both of these steps.
Adverse events	None of the subjects who participated in the study had adverse events.
Outcome measures	In the microbiota in the denture plaque, the most abundant phylum was Firmicutes (84%), followed by Proteobacteria (6.1%), Bacteroidetes (5.2%), and Actinobacteria (1.9%) .DNA analysis showed a decrease in the amount of denture plaque attached before and after coating, and the Shannon index was 1.68 and 1.74, and the BC index was 0.14, suggesting that the coating does not affect the bacterial flora.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 02 Month 14 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 01 Month 15 Day
Last modified on	2021 Year 08 Month 17 Day

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