UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of a new oral plaque removal device using the micro-scale mist
Title of the study (Brief title)	Oral plaque removal test by the micro-scale mist
Region	Japan

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

Objectives
Narrative objectives1	We comfirm the efficacy and safety of new oral plaque removal equipment by pain assessment and cleaning rate after mist injection into the maxillary central incisor both sides and to the hard palate.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	(1) cleaning rate after mist injection into the upper jaw on both sides central incisor (comparison of before and after treatment) (2) assessment of pain immediately after and one day after the mist injection into the hard palate portion and the gingibal. (3) assessment of inflammation immediately after and one day after the mist injection into the hard palate portion and the gingibal.
Key secondary outcomes	(1) adverse events and the failure

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	The inject the mist for 20 seconds to the upper and middle side incisors and palate
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	A healthy Men and Women over 20 years of age at the time of obtaining informed consent
Key exclusion criteria	(1) a person who has a significant malocclusions and periodontal disease (2) Persons who have periodontal diseases (periodontitis, gingivitis, etc.) of BOP (+) with periodontal pocket of 5 mm or more in both maxillary middle incisors (3) Persons with dental caries or medical history on the maxillary both-side central incisors (4) a person who has oral mucosal disease (5) those with vomiting reflex (6) Other, who one and principal investigator with systemic disease or research team members has judged it difficult to participate in test
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	Takeshi Fuji
Organization	Tohoku University Graduate School of Dentistry
Division name	Comprehensive Education Center for Community Medicine
Address	4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL	022-717-8369
Homepage URL
Email	f-takeshi@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
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	2017 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 14 Day
Anticipated trial start date	2017 Year 02 Month 14 Day
Last follow-up date	2017 Year 03 Month 17 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Plaque removal test on the tooth surface and safety assessment test on the palate and gingiva were performed on five healthy dentated chin. Regarding the effectiveness of plaque removal, reduction of plaque on the tooth surface was confirmed, but in some cases it could not be said that it is clinically adequate effect, and it is considered that investigation of injection distance and injection time is necessary from now on It was. For safety assessment, it is considered that safety can be secured under the conditions of use in this clinical trial without changing VAS or inflammatory findings in the palate, gums, gingiva and examination of the evaluation of the effectiveness of plaque removal in the palate from now on is necessary. As a future task, confirmation of effectiveness to molar parts and establishment of evaluation index at that time are necessary. No adverse events were observed in the use of this instrument.
Other related information

Management information
Registered date	2017 Year 02 Month 11 Day
Last modified on	2017 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029030