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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02190773
Other study ID # RANKL
Secondary ID
Status Completed
Phase N/A
First received July 8, 2014
Last updated July 13, 2014
Start date January 2010
Est. completion date April 2013

Study information

Verified date July 2014
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary RANKL (pmol) level in GCF Changes in RANKL levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA Baseline-3 months No
Primary OPG level (pg) in GCF Changes in OPG levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA Baseline-3 months No
Primary RANKL/OPG ratio RANKL/OPG ratio changes 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis Baseline - 3months No
Secondary IL-1ß (pg) levels in GCF Changes in IL-1ß levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive Periodontitis groups Baseline, 3 months after treatment No
Secondary Il-10 (pg) levels in GCF Changes in IL-10 levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis Baseline-3 months No
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