UMIN-CTR Clinical Trial

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
Email	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
Email	mizuperi@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045422