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Completed

NCT Number: NCT02190773

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

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.

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Key information

Conditions

Chronic Periodontitis Aggressive Periodontitis Chronic Disease Disease Attributes Gingival Crevicular Fluid Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis RANKL/OPG Ratio Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Effect of Surgical Periodontal Therapy on the RANKL/OPG System : Do we Need Osteo-immune Modulation Targeting RANKL?

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 15, 2014
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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