- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190773
Effect of Surgical Therapy on RANKL/OPG (Osteoprotegerin) System
July 13, 2014 updated by: Ezel Berker, Hacettepe University
Effect of Surgical Periodontal Therapy on the RANKL/OPG System : Do we Need Osteo-immune Modulation Targeting RANKL?
In the present clinical study including chronic, aggressive periodontitis and healthy individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG), Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after surgical periodontal treatment and search out the relationship of clinical parameters with these cytokine levels.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
65
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
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Ankara, Turkey, 06100
- Hacettepe University
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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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individulas that applied to periodontology clinic in faculty of dentistry, Hacettepe University.
Description
Inclusion Criteria:
- Chronic periodontitis having at least 5mm or more probing depth and aggressive periodontitis patients.
Exclusion Criteria:
- Any known systemic disorder, used antibiotics and/or anti-inflammatory medications, had periodontal treatment in the last 3 months and all of them were non smokers. Subjects who were lactating and pregnant were also excluded.
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 |
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Chronic periodontitis
Surgical periodontal treatment and GCF collection 3 months after treatment
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Agressive periodontitis
Surgical periodontal treatment and GCF collection 3 months after treatment.
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Control group
Periodontally healthy individuals
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RANKL (pmol) level in GCF
Time Frame: Baseline-3 months
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Changes in RANKL levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA
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Baseline-3 months
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OPG level (pg) in GCF
Time Frame: Baseline-3 months
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Changes in OPG levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA
|
Baseline-3 months
|
RANKL/OPG ratio
Time Frame: Baseline - 3months
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RANKL/OPG ratio changes 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis
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Baseline - 3months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IL-1β (pg) levels in GCF
Time Frame: Baseline, 3 months after treatment
|
Changes in IL-1β levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive Periodontitis groups
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Baseline, 3 months after treatment
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Il-10 (pg) levels in GCF
Time Frame: Baseline-3 months
|
Changes in IL-10 levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis
|
Baseline-3 months
|
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
January 1, 2010
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
July 8, 2014
First Submitted That Met QC Criteria
July 13, 2014
First Posted (Estimate)
July 15, 2014
Study Record Updates
Last Update Posted (Estimate)
July 15, 2014
Last Update Submitted That Met QC Criteria
July 13, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RANKL
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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