- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507868
YKL-40 and IL-6 Levels in Periodontal Disease
April 16, 2018 updated by: Zeynep Pinar KELES
Effect of Non-Surgical Periodontal Therapy on Salivary and Gingival Crevicular Fluid YKL-40 and IL-6 Levels in Chronic Periodontitis
The primer aim of the study was to investigate saliva and gingival crevicular fluid (GCF) YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study consisted of two groups: 26 periodontally healthy individuals and 26 generalized chronic periodontitis patients.
Chronic periodontitis patients were received nonsurgical periodontal treatment.
Clinical measurements were recorded, saliva and GCF samples were obtained before and at first and third months after periodontal therapy.
Levels of YKL-40 and IL-6 in saliva and GCF were analyzed by enzyme-linked immunosorbent assay.
Study Type
Observational
Enrollment (Actual)
52
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
26 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A total of 52 participants
Description
Inclusion Criteria:
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,
- 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 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Periodontally healthy individuals
|
|
|
Group 2
Chronic periodontitis patients
|
Nonsurgical periodontal therapy includes oral hygiene education and scaling and root planning approaches to eliminate microbial dental plaque that is the primary etiology of periodontal diseases.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
YKL-40 levels
Time Frame: at first and third month after therapy
|
changes in YKL-40 levels after periodontal therapy
|
at first and third month after therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IL-6 levels
Time Frame: at first and third month after therapy
|
changes in IL-6 levels after periodontal therapy
|
at first and third month after therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
September 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
April 16, 2018
First Submitted That Met QC Criteria
April 16, 2018
First Posted (Actual)
April 25, 2018
Study Record Updates
Last Update Posted (Actual)
April 25, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/1003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.