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
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
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
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
