UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trials for evaluating the effectiveness and safty of a new dental biofilm removing device (MSM-UNIT)
Acronym	Clinical trials for a new dental biofilm removing device (MSM-UNIT)
Scientific Title	Clinical trials for evaluating the effectiveness and safty of a new dental biofilm removing device (MSM-UNIT)
Scientific Title:Acronym	Clinical trials for a new dental biofilm removing device (MSM-UNIT)
Region	Japan

Condition
Condition	Oral hygiene failure
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of study is to comfirm the efficacy and safety of removing biofilm on oral mucosa and tooth by using MSM-UNIT.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1)Teeth Plaque cleaning rate by PCR (2)Platal mucosa Removal rate of plaque on platal mucosa (3)Tongue Removal rate of plaque on tongue
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	1 minute injection of mist to palatal mucosa (up to 3 times)
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	(1)Men and Women over 20 years of age at the time of obtaining informed consent (2)Patients had a plaque on tongue, palatl mucosa and teeth and the judged "high" or more biofilm adhesion rate nt (3)Patients who agreed with the document to participate in this research
Key exclusion criteria	(1) Patient who has severe hyperesthesia (2) Patient who have periodontitis of BOP (+) with periodontal pocket of 6 mm or more in More than half of all jaws. (3)Patients who can not stop taking analgesic from the day before pain evaluation (4) Ptients who have judged that it is difficlt to participate in this trail
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Keiichi Middle name Last name Sasaki
Organization	Tohoku University Graduate School of Dentistry
Division name	Advanced Prosthetic Dentistry
Zip code	9808575
Address	4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL	022-717-8368
Email	keiichi.sasaki.e6@tohoku.ac.jp

Public contact
Name of contact person	1st name Hihara Middle name Last name Hiroki
Organization	Tohoku Universiry Hospital
Division name	Advanced Prosthetic Dentistry
Zip code	9808575
Address	4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL	022-717-8369
Homepage URL
Email	hihara@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Morita corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University Hospital Institutional Review Board
Address	1-1 Seiryo-machi, Aoba-ku,Sendai,Japan
Tel	022-717-7056
Email	chiken@grp.tohoku.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 03 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	15
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	2019 Year 02 Month 15 Day
Date of IRB	2019 Year 01 Month 25 Day
Anticipated trial start date	2019 Year 02 Month 25 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 20 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040945