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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021390
Receipt No. R000024668
Scientific Title Analysis of bacterial flora in peri-implant crevicular fluid and application for clinical treatment of peri-implantitis.
Date of disclosure of the study information 2016/03/08
Last modified on 2019/09/10

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Basic information
Public title Analysis of bacterial flora in peri-implant crevicular fluid and application for clinical treatment of peri-implantitis.
Acronym Crevicularl microbiomes in peri-implantitis.
Scientific Title Analysis of bacterial flora in peri-implant crevicular fluid and application for clinical treatment of peri-implantitis.
Scientific Title:Acronym Crevicularl microbiomes in peri-implantitis.
Region
Japan

Condition
Condition Peri-implantitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Debridement of the surface for regenerative therapy of an infected dental implant is considered difficult. Analysis of bacterial flora may contribute to the conservation of the implant by evaluation of bacteria elimination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy of flora analysis in peri-implant crevicular as an evaluation method for bacteria elimination.
Key secondary outcomes Confirmation of the effect of antibiotics which selected based on the result of bacterial analysis.

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 Prevention
Type of intervention
Other
Interventions/Control_1 Selection of antibiotics based on the result of bacterial analysis.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Dental implants which suffer from peri-implantitis.
Key exclusion criteria Maladaptive systemic conditions for surgical procedure.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hidemi
Middle name
Last name Nakata
Organization Tokyo Medical and Dental University
Division name Oral Implantology and Regenerative Dental Medicine
Zip code 113-8549
Address Yushima1-5-45 Bunkyo-ku Tokyo
TEL 03-5803-4656
Email hidemi.irm@tmd.ac.jp

Public contact
Name of contact person
1st name Hidemi
Middle name
Last name Nakata
Organization Tokyo Medical and Dental University
Division name Oral Implantology and Regenerative Dental Medicine
Zip code 113-8549
Address Yushima1-5-45 Bunkyo-ku Tokyo
TEL 03-5803-4656
Homepage URL
Email hidemi.irm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization DENTALEAD CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address Yushima1-5-45 Bunkyo-ku Tokyo
Tel 0358034656
Email hidemi.irm@tmd.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 東京医科歯科大学 歯学部附属病院 インプラント外来(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 08 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 08 Day
Date of IRB
2016 Year 04 Month 01 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 08 Day
Last modified on
2019 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024668

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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