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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016791
Receipt No. R000019492
Scientific Title Clinical trial for evaluation of efficacy and safety of the therapeutic device(RP-14) based on disinfection technique utilizing photolysis of hydrogen peroxide for moderate-severe chronic periodontitis
Date of disclosure of the study information 2015/04/15
Last modified on 2017/10/02

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Basic information
Public title Clinical trial for evaluation of efficacy and safety of the therapeutic device(RP-14) based on disinfection technique utilizing photolysis of hydrogen peroxide for moderate-severe chronic periodontitis
Acronym Clinical trial for evaluation of periodonal treatment using the therapeutic device(RP-14)
Scientific Title Clinical trial for evaluation of efficacy and safety of the therapeutic device(RP-14) based on disinfection technique utilizing photolysis of hydrogen peroxide for moderate-severe chronic periodontitis
Scientific Title:Acronym Clinical trial for evaluation of periodonal treatment using the therapeutic device(RP-14)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy and safety of the periodontal treatment using RP-14 comparing with those of standard treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Probing pochet depth
Key secondary outcomes Probing pocket depth
Bleeding on Probing
Bacteriological examination

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Root debridement together with disinfection treatment using novel therapeutic device(RP-14)
Interventions/Control_2 Root debridement
Interventions/Control_3 Root debridement followed by local drug delivery system
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 suffering from moderate to severe chronic periodontitis
・Patients having at least 18 remaining teeth
・Patients having >=1 tooth with PPD in a range of 6-9 mm in at least two quadrants
・Patients with no systemic complication
Key exclusion criteria ・Smoker
・Pregnant women
・Patiants who recieved antibiotics within the last 84 days
・Patiants who received periodontal therapy within the last 84 days
・Patiants who takes medication that may affect the clinical conditions of periodontal disease
Target sample size 55

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Keiichi Sasaki
Organization Tohoku University Graduate School of Dentistry
Division name Division of Advanced Prosthetic Dentistry
Zip code
Address 4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-8363
Email keii@dent.tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Taro Kanno
Organization Tohoku University Graduate School of Dentistry
Division name Division of Molecular and Regenerative 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 MHLW
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 東北大学病院歯科(宮城県)、スウェーデンデンタル仙台(宮城県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 15 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
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 07 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 06 Day
Last follow-up date
2016 Year 04 Month 25 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 08 Month 19 Day
Date analysis concluded
2017 Year 02 Month 08 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 13 Day
Last modified on
2017 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019492

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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