UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026097 |
|---|---|
| Receipt number | R000029030 |
| Scientific Title | Clinical trial of a new oral plaque removal device using the micro-scale mist |
| Date of disclosure of the study information | 2017/02/16 |
| Last modified on | 2017/04/22 11:06:51 |
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Basic information
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
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
| 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
keii@dent.tohoku.ac.jp
Public contact
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
f-takeshi@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
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
Progress
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029030
