- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02750956
Endocan, VEGF and TNF-alpha Levels in Periodontal Disease and After Treatment
April 21, 2016 updated by: ÇİĞDEM COŞKUN TÜRER, Bulent Ecevit University
Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Endocan, Vascular Endothelial Growth Factor-A and Tumor Necrosis Factor Alpha Levels
The primer aim of the study was to determine serum and gingival crevicular fluid (GCF) endocan levels in periodontal diseases pathogenesis supported with vascular endothelial growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study consist of three groups: periodontally healthy individuals (group 1; n = 20), individuals with generalized chronic periodontitis (group 2; n = 20), the same patients with chronic periodontitis after they had been treated with scaling and root planing (SRP) were considered as Group 3. Clinical measurements were recorded; GCF and serum samples were obtained from each participant before and 6 weeks after therapy.
Endocan, VEGF-A and TNF-α levels were measured by enzyme-linked immunosorbent assay.
Study Type
Observational
Enrollment (Actual)
40
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 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Total of 40 individuals
Description
Group 1 Inclusion Criteria:
- No bone and attachment loss,
- GI=0, PPD≤3mm, CAL≤3mm
- Systematically healthy patients
Group 2 Inclusion Criteria:
- GI>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
- Systematically healthy patients
Exclusion Criteria:
- Aggressive Periodontitis,
- Oral pathologies,
- Patients with any other systemic diseases,
- Pregnant women and those in the lactation period,
- Patients with smoking habit and taking medication
- Patients received periodontal therapy in last 6 months
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Periodontal healthy individuals
|
|
Group 2
Patients with chronic periodontitis
|
Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis
|
Group 3
the same patients in group 2 after they had been treated with scaling and root planing (SRP) were considered as Group 3.
|
Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endocan levels
Time Frame: 6 weeks
|
Change after periodontal treatment
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VEGF levels
Time Frame: 6 weeks
|
Change after periodontal treatment
|
6 weeks
|
TNF-alpha levels
Time Frame: 6 weeks
|
Change after periodontal treatment
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ÇİĞDEM COŞKUN TÜRER, BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY
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
June 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
April 19, 2016
First Submitted That Met QC Criteria
April 21, 2016
First Posted (Estimate)
April 26, 2016
Study Record Updates
Last Update Posted (Estimate)
April 26, 2016
Last Update Submitted That Met QC Criteria
April 21, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Endocan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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