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Effect of Surgical Therapy on RANKL/OPG (Osteoprotegerin) System

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ClinicalTrials.gov Identifier: NCT02190773
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Ezel Berker, Hacettepe University

Brief Summary:
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.

Condition or disease
Chronic Periodontitis Aggressive Periodontitis RANKL/OPG Ratio Gingival Crevicular Fluid

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Surgical Periodontal Therapy on the RANKL/OPG System : Do we Need Osteo-immune Modulation Targeting RANKL?
Study Start Date : January 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Group/Cohort
Chronic periodontitis
Surgical periodontal treatment and GCF collection 3 months after treatment
Agressive periodontitis
Surgical periodontal treatment and GCF collection 3 months after treatment.
Control group
Periodontally healthy individuals



Primary Outcome Measures :
  1. RANKL (pmol) level in GCF [ Time Frame: Baseline-3 months ]
    Changes in RANKL levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA

  2. OPG level (pg) in GCF [ Time Frame: Baseline-3 months ]
    Changes in OPG levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA

  3. RANKL/OPG ratio [ Time Frame: Baseline - 3months ]
    RANKL/OPG ratio changes 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Description:
Gingival Crevicular fluid (GCF) is collected at baseline and 3 months after the surgical treatment.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individulas that applied to periodontology clinic in faculty of dentistry, Hacettepe University.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190773


Locations
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Turkey
Hacettepe University
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University

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Responsible Party: Ezel Berker, Hacettepe University
ClinicalTrials.gov Identifier: NCT02190773     History of Changes
Other Study ID Numbers: RANKL
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014

Keywords provided by Ezel Berker, Hacettepe University:
Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG ratio, Gingival crevicular fluid

Additional relevant MeSH terms:
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Periodontitis
Aggression
Chronic Periodontitis
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms