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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011511
Receipt No. R000013467
Scientific Title Clinical evaluation of a novel device for the treatment of periodontitis by applying a photolysis of hydrogen peroxide disinfection technique
Date of disclosure of the study information 2013/08/23
Last modified on 2016/08/05

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Basic information
Public title Clinical evaluation of a novel device for the treatment of periodontitis by applying a photolysis of hydrogen peroxide disinfection technique
Acronym A new disinfection device for the treatment of periodontitis
Scientific Title Clinical evaluation of a novel device for the treatment of periodontitis by applying a photolysis of hydrogen peroxide disinfection technique
Scientific Title:Acronym A new disinfection device for the treatment of periodontitis
Region
Japan

Condition
Condition Periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to verify the safety and the efficacy of a novel device for the treatmet of periodontal disease by applying photolysis of hydrogen peroxide disinfection technique.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Probing pocket depth
Key secondary outcomes Bacteriological examination, Gingival index, Plaque index, Clinical attachment level, Bleeding on probing, Gingival resession

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Root debridement using the novel device
Interventions/Control_2 Root debridement using the conventional ultrasound scaler
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
35 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients who suffer from generalized chronic periodontitis with 8 or more teeth which have >=6mm periodontal pocket and show positive of bleeding on plobing.
Patients who have 18 or more remaining teeth.
Patients who is systematically healthy.
Key exclusion criteria Smoker
Pregnant female
Patients who have had antibiotics within the last 6 months.
Patients who have had the periodontal treatment with the subgingival aria within the last 12 months.
Patients who uses a medicine to affect for the clinical sign of periodontal disease.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Shimauchi
Organization Tohoku University Graduate School of Dentistry
Division name Division of Periodontology and Endodontology
Zip code
Address 4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-8363
Email simauti@dent.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taro Kanno
Organization Tohoku University Graduate School of Dentistry
Division name Division of Fixed Prosthodontics
Zip code
Address 4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-8363
Homepage URL
Email tarou@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 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
2013 Year 08 Month 23 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
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
2013 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 18 Day
Last modified on
2016 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013467

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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