UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trials for evaluating the effectiveness of a new dental biofilm removing device on palatine mucosa
Title of the study (Brief title)	Clinical trials evaluating the effectiveness of new dental biofilm removing device
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 this study is constructing an effective index for removing biofilm on oral mucosa by using a new dental biofilm removing device for patients with biofilm on palatine mucosa and gathering information for deciding how to use.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Removal rate of biofilm on platal mucosa
Key secondary outcomes	1.Time to remove all biofilm on platal mucosa 2.Cleaning rate(comparison before and after treatment)

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	30 seconds injection of mist to palatal mucosa (up to 6 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 in Tohoku University Hospital of dentistry and had a biofilm on palatl mucosa and the judged "high" or more biofilm adhesion rate (3)Patinets who can receive ambulatory treatment (4)Patients who agreed with the document to participate in this research (5)Patients who do not have communication disorder
Key exclusion criteria	(1)Patients who has oral mucosal disease (2)Patinets with severe vomiting reflex (3)Patients who can not stop taking analgesic from the day before pain evaluation (4)Patients who have judged that it is difficlt to participate in this trail
Target sample size	5

Research contact person
Name of lead principal investigator	Keiichi Sasaki
Organization	Tohoku University Graduate School of Dentistry
Division name	Advanced Prosthetic Dentistry
Address	4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL	022-717-8368
Email	keii@dent.tohoku.ac.jp

Public contact
Name of contact person	Hiroki Hihara
Organization	Tohoku Universiry Hospital
Division name	Advanced Prosthetic Dentistry
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)

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	2018 Year 02 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 09 Day
Anticipated trial start date	2018 Year 02 Month 21 Day
Last follow-up date	2018 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 03 Month 19 Day
Date analysis concluded	2018 Year 03 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 09 Day
Last modified on	2018 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035612