NCT02417363

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

April 10, 2015

Last Update Submit

April 16, 2015

Conditions

Keywords

biomarkersrenal diseaseperiodontitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples are placed into 1.5 ml Eppendorf tubes and maintained at -70℃ for further analysis

MeSH Terms

Conditions

PeriodontitisKidney Diseases

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Hui Chen

    Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The stomatological hospital affiliated to medical college, Zhejiang University

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 15, 2015

Study Start

October 1, 2013

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations