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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035950
Receipt No. R000040945
Scientific Title Clinical trials for evaluating the effectiveness and safty of a new dental biofilm removing device (MSM-UNIT)
Date of disclosure of the study information 2019/03/01
Last modified on 2019/08/21

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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 No longer recruiting
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 08 Month 21 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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