UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of inhibitory effect of MPC polymer on oral bacterial colonization
Title of the study (Brief title)	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	Yoichiro Miyake
Organization	Tokushima University Graduated School
Division name	Department of Oral Microbiology
Address	3-18-15 Kuramoto cho, Tokushima city
TEL	088-633-7329
Email	miyake@tokushima-u.ac.jp

Public contact
Name of contact person	Natsumi Fujiwara
Organization	Tokushima University Graduated School
Division name	Department of Oral Microbiology
Address	3-18-15 Kuramoto cho, Tokushima city
TEL	088-633-7898
Homepage URL
Email	nfujiwara@tokushima-u.ac.jp

Sponsor
Institute	Department of Oral Microbiology, Tokushima University Graduated School
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021464