UMIN-CTR Clinical Trial

Public title

Clinical trial of a new oral plaque removal device using the micro-scale mist

Acronym

Oral plaque removal test by the micro-scale mist

Scientific Title

Clinical trial of a new oral plaque removal device using the micro-scale mist

Scientific Title:Acronym

Oral plaque removal test by the micro-scale mist

Region

Japan

Condition

Oral hygiene failure
Aspiration pneumonia

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Keiichi Sasaki

Organization

Tohoku University Graduate School of Dentistry

Division name

Advanced Prosthetic Dentistry

Zip code

Address

4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan

TEL

022-717-8368

Email

keii@dent.tohoku.ac.jp

Name of contact person

1st name
Middle name
Last name	Takeshi Fuji

Organization

Tohoku University Graduate School of Dentistry

Division name

Comprehensive Education Center for Community Medicine

Zip code

Address

4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan

TEL

022-717-8369

Homepage URL

Email

f-takeshi@dent.tohoku.ac.jp

Institute

Tohoku University Graduate School of Dentistry

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

16

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

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.

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

02

Month

14

Day

Date of IRB

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

Other related information

Registered date

2017

Year

02

Month

11

Day

Last modified on

2017

Year

04

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029030