UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021390 |
|---|---|
| Receipt number | 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 09:22:48 |
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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
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
hidemi.irm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024668
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
