Study on the Relationship Between Periodontitis and Renal... | NCT02417363

Studies
Study on the Relationship Between Periodontitis and Renal Disease

NCT02417363

Sponsor

Zhejiang University

Status

Unknown status

Last Update Posted

Apr 17, 2015Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Periodontitis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Aug 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Apr 10, 2015

First Submission Date that Met QC Criteria

Apr 14, 2015

First Posted Date

Apr 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2015

Last Update Posted Date

Apr 17, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Na Zhou, The stomatological hospital affiliated to medical college, Zhejiang University, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Na Zhou	Contact	86-571-87217437		kate0228@163.com
Yan Tu	Contact	86-571-87217437		tuyan1984@hotmail.com

Overall Officials

Name	Affiliation	Role
Hui Chen	Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310006	China

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided