UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038632
Receipt No. 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 (Ver. 1)

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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
Email 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
Email shweirm@tmd.ac.jp

Sponsor
Institute Oral Implantology and Regenerative Dental Medicine Department ,Tokyo Medical and Dental University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044021