UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035554
Receipt number 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 2021/08/17 15:49:21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Showa University

Institute

Department

Personal name



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

Value
https://center6.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