UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039845 |
|---|---|
| Receipt number | R000045422 |
| Scientific Title | the effects of periodontitis and periodontal treatment on chronic kidney disease |
| Date of disclosure of the study information | 2020/03/20 |
| Last modified on | 2020/03/17 12:26:05 |
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Basic information
Public title
the effects of periodontitis and periodontal treatment on chronic kidney disease
Acronym
the effects of periodontitis and periodontal treatment on chronic kidney disease
Scientific Title
the effects of periodontitis and periodontal treatment on chronic kidney disease
Scientific Title:Acronym
the effects of periodontitis and periodontal treatment on chronic kidney disease
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is known that the prevalence of periodontal disease is high in chronic kidney disease patients, and it has been reported that periodontal treatment improves renal function-related markers. However, the detailed mechanism and the effectiveness of periodontal treatment on systemic condition are not revealed. The purpose of this study is to perform a cross-sectional and a longitudinal survey of periodontal disease in chronic kidney disease patients and to clarify the effects of periodontal treatment on renal function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hsCRP, Hb, HbA1c, Cr, ALP, Alb, Ca, P, KT/V, nPCR
Key secondary outcomes
TNF-a,TNFRs,IL-1,IL-6,OPG,OPN,PTH,RANK,RANKL,25-hydroxyvitamin D,MMPs,TIMPs,MCP-1,FGF23,IgG antibody of periodontal bacteria (P. gingivalis etc.)
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. 20 years old and more
2. Subjects who have given the informed consent after receiving sufficient explanations for participating in this study
Key exclusion criteria
1. Undergoing treatment for serious acute illness
2. Those with serious complications that severely limit their life expectancy
3. Infectious disease such as hepatitis B, hepatitis C, and HIV
4. Subjects who is disqualified by a doctor
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Mizutani |
Organization
Tokyo Medical and Dental University
Division name
Department of periodontology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku
TEL
0358035488
mizuperi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Mizutani |
Organization
Tokyo Medical and Dental University
Division name
Department of periodontology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku
TEL
0358035488
Homepage URL
mizuperi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Department of Periodontology, Tokyo Medical and Dental university
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0358035488
mizuperi@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
| 2020 | Year | 03 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The medical information on the electronic medical record and blood test data are obtained from the participants undergoing hemodialysis who gave informed consent. In addition, dental examination and saliva collection for bacterial tests are performed. The data is statistically analyzed.
Management information
Registered date
| 2020 | Year | 03 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045422
| 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 |
