UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038632 |
|---|---|
| Receipt number | R000044021 |
| Scientific Title | Examination of changes of bacteria and cytokines existing around peri-implantitis |
| Date of disclosure of the study information | 2019/11/19 |
| Last modified on | 2019/11/19 15:30:57 |
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Basic information
Public title
Examination of changes of bacteria and inflammatory parameters existing around dental implant
Acronym
Examination of changes of bacteria and inflammatory parameters existing around dental implant
Scientific Title
Examination of changes of bacteria and cytokines existing around peri-implantitis
Scientific Title:Acronym
Examination of changes of bacteria and cytokines existing around peri-implantitis
Region
| Japan |
Condition
Condition
Dental Implantitis treatment
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is important to maintain the dental implant functioning properly in the oral cavity. This study aim to evaluate bacterial and inflammatory cytokines of the oral cavity during and after treatment of peri-implantitis
Basic objectives2
Others
Basic objectives -Others
To evaluate the important bacteria and cytokines in peri-implantiitis and to correlate them with clinical parameters
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Peri-implant bacteria and inflammatory cytokines changes during the course of non surgical treatment
Key secondary outcomes
Clinical parameters such as Peri-implant pocket depth and gingival index
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Peri- implant pocket depth of more than 5 millimeters and radiographic evident of bone loss and bleeding on probing
Key exclusion criteria
Peri-implant mucosititis
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Kasugai |
Organization
Tokyo Meidical and Dental University
Division name
Oral Implantology and Regenerative Dental Medicine
Zip code
113-8549
Address
1-5-45 Yushima Bunky-ku
TEL
03-5803-5773
kas.mfc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yee |
| Middle name | Mon |
| Last name | Shwe |
Organization
Tokyo Medical and Dental University
Division name
Oral Implantology and Regenerative Dental Medicine
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku
TEL
90-3227-7669
Homepage URL
shweirm@tmd.ac.jp
Sponsor or person
Institute
Oral Implantology and Regenerative Dental Medicine Department ,Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Oral Implantology and Regenerative Dental Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyu-ku
Tel
03-5803-5773
shweirm@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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 19 | 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
13
Results
The non surgical treatment provides the considerable reduction of bacteria and inflammatory cytokines
Results date posted
| 2019 | Year | 11 | Month | 19 | Day |
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
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The non surgical treatment of peri- implantiits provides the considerable amount of reduction of bacteria and inflammatory cytokines
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2019 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044021
| 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 |
