Study on the Relationship Between Periodontitis and Renal Disease

April 16, 2015 updated by: Na Zhou, Zhejiang University

Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University

Analysis of inflammatory markers in periodontitis and patients with early and middle stage renal disease.

Study Overview

Status

Unknown

Conditions

Detailed Description

A total of 200 population is recruited, individuals are divided into four groups according to a periodontal examination and a general physical examination: healthy individuals ,periodontitis, renal disease patients with healthy periodontium, and renal disease patients wth peridontitis. Fasting blood samples and gingival crevicular fluid are collected from all individuals, and inflammatory markers are analysed for the four groups.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
        • Contact:
        • Principal Investigator:
          • Na Zhou
        • Sub-Investigator:
          • Yan Tu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 individuals are recruited for each group, the factors of age and gender are matched while selecting the incruited indiduals,all participants were in general good health(except renal disease) and non-smoking.

Description

Inclusion Criteria:

  • all participants were in general good health(except renal disease) and non-smoking

Exclusion Criteria:

  • less than 20 teeth in the dentin
  • hypertension
  • the presence of systemic disease (e.g., diabetes mellitus ,coronary heart disease, liver, or lung disease)
  • a history or the symptom of any other acute or chronic infections
  • systemic antibiotic treatment within previous 4 weeks
  • periodontal treatment within1 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Group A
the control group,healthy individuals
Group B
patients with 1-4 stage K/DOQI (Kidney Disease Outcome Quality Initiative) chronic kidney disease, but healthy periodontium
Group C
patients with periodontitis, but healthy renal conditions
Group D
patients with 1-4 stage K/DOQI (Kidney Disease Outcome Quality Initiative) chronic kidney disease and periodontitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory markers analysis of the four groups
Time Frame: 3 months after sampling
Analysis of inflammatory biomarkers of blood and gingival crevicular fluid samples of the four groups
3 months after sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Study Director: Hui Chen, Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJUSH2015-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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