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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190773
• Other study ID #: RANKL
• 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

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Chronic Periodontitis
• Gingival Crevicular Fluid
• Periodontitis
• RANKL/OPG Ratio

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