UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000024668