UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018551 |
|---|---|
| Receipt number | R000021464 |
| Scientific Title | The study of inhibitory effect of MPC polymer on oral bacterial colonization |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2018/02/15 10:26:59 |
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Basic information
Public title
The study of inhibitory effect of MPC polymer on oral bacterial colonization
Acronym
The study of effect of MPC polymer on oral bacterial colonization
Scientific Title
The study of inhibitory effect of MPC polymer on oral bacterial colonization
Scientific Title:Acronym
The study of effect of MPC polymer on oral bacterial colonization
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the inhibitory effect of MPC polymer on oral bacterial colonization
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of oral bacteria before rinsing by MPC polymer and after 5hours of rinsing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
5%MPC polymer
Interventions/Control_2
0.25%MPC polymer
Interventions/Control_3
0.025%MPC polymer
Interventions/Control_4
placebo
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The person who have healthy 25 teeth or more
Key exclusion criteria
The person who have severe caries or periodontal disease
The person who are taking antibiotics
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichiro Miyake |
Organization
Tokushima University Graduated School
Division name
Department of Oral Microbiology
Zip code
Address
3-18-15 Kuramoto cho, Tokushima city
TEL
088-633-7329
miyake@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsumi Fujiwara |
Organization
Tokushima University Graduated School
Division name
Department of Oral Microbiology
Zip code
Address
3-18-15 Kuramoto cho, Tokushima city
TEL
088-633-7898
Homepage URL
nfujiwara@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Oral Microbiology, Tokushima University Graduated School
Institute
Department
Personal name
Funding Source
Organization
NOF CORPORATION
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2015 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 05 | Day |
Last modified on
| 2018 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021464
