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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020175
Receipt No. R000020223
Scientific Title Clinical assesment on the scaling ability with DU12 vibrating rotary scaler
Date of disclosure of the study information 2015/12/14
Last modified on 2017/07/12

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Basic information
Public title Clinical assesment on the scaling ability with DU12 vibrating rotary scaler
Acronym DU12 vibrating scaler clinical assesment
Scientific Title Clinical assesment on the scaling ability with DU12 vibrating rotary scaler
Scientific Title:Acronym DU12 vibrating scaler clinical assesment
Region
Japan

Condition
Condition chronic periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the ability on scaling using an eccentic vibrating motor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes archieving the scaling
Key secondary outcomes archieving the safety scaling as same as hand-scaler

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 One scaling using bibrating scaler within 5 minutes
Interventions/Control_2 One scaling using normal scaler within 5 minutes
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
99 years-old >=
Gender Male and Female
Key inclusion criteria light to moderate periodontitis
Key exclusion criteria 1,endoperio disease
2,smoker
3,diabe disease
4,having follow drug (anti, fenitoin,anti-calcium)
5,ferrog

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Shoji
Organization Tohoku University Hospital
Division name Periodontics
Zip code
Address 1-1 Seiryo-machi, Aobaku, Sendai city
TEL 022-717-8334
Email shoji@dent.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoki Kadota
Organization Tohoku University Hospital
Division name CRIETO
Zip code
Address 1-1 Seiryo, Aobaku, Sendai
TEL 022-717-7136
Homepage URL
Email kadota@hosp.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University Hospital CRIETO
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 DU17
Org. issuing International ID_1 MICRON Inc.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.hozon.or.jp
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2015 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 07 Day
Last follow-up date
2016 Year 02 Month 28 Day
Date of closure to data entry
2016 Year 03 Month 09 Day
Date trial data considered complete
2016 Year 03 Month 15 Day
Date analysis concluded
2016 Year 03 Month 20 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 12 Day
Last modified on
2017 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020223

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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