Osteoprotegerin Before and After Periodontal Surgery

Chronic Periodontitis Clinical Trial

Official title:

Effect of Periodontal Surgery on Osteoprotegerin Levels in Gingival Crevicular Fluid, Saliva and Gingival Tissues.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160613
• Other study ID #: OPG_OFD
• Status: Completed
• Phase: N/A
• First received: June 7, 2014
• Last updated: June 7, 2014
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: June 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study hypothesis:

Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?

Description:

assessment of osteoprotegerin in patients with chronic periodontitis before and after periodontal surgery in gingival crevicular fluid, saliva and gingival tissues.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 32 Years to 55 Years

Eligibility

Inclusion Criteria:

• severe chronic periodontitis, having pocket depth of = 5 mm and clinical attachment level = 5 mm

Exclusion Criteria:

• pregnant women

• subjects had <22 permanent teeth

• having any given systemic disease

• taking any type of medication and/or antibiotic therapy during the 3 months before the study

• received periodontal treatment within the past 12 months

• current or former smokers.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• Open flap debridement
an access flap

Locations

Country	Name	City	State
Egypt	Faculty of oral and dental medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Töz H, Atilla G, Hughes FJ, Belibasakis GN. Gingival crevicular fluid levels of RANKL and OPG in periodontal diseases: implications of their relative ratio. J Clin Periodontol. 2007 May;34(5):370-6. Epub — View Citation

Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Töz H, Berdeli A, Atilla G, McKay IJ, Hughes FJ, Belibasakis GN. Differential expression of receptor activator of nuclear factor-kappaB ligand and osteoprotegerin mRNA in periodontal diseases. J Periodont — View Citation

Bostanci N, Saygan B, Emingil G, Atilla G, Belibasakis GN. Effect of periodontal treatment on receptor activator of NF-?B ligand and osteoprotegerin levels and relative ratio in gingival crevicular fluid. J Clin Periodontol. 2011 May;38(5):428-33. doi: 10 — View Citation

Buduneli N, Buduneli E, Kütükçüler N. Interleukin-17, RANKL, and osteoprotegerin levels in gingival crevicular fluid from smoking and non-smoking patients with chronic periodontitis during initial periodontal treatment. J Periodontol. 2009 Aug;80(8):1274- — View Citation

Costa PP, Trevisan GL, Macedo GO, Palioto DB, Souza SL, Grisi MF, Novaes AB Jr, Taba M Jr. Salivary interleukin-6, matrix metalloproteinase-8, and osteoprotegerin in patients with periodontitis and diabetes. J Periodontol. 2010 Mar;81(3):384-91. doi: 10.1 — View Citation

Crotti T, Smith MD, Hirsch R, Soukoulis S, Weedon H, Capone M, Ahern MJ, Haynes D. Receptor activator NF kappaB ligand (RANKL) and osteoprotegerin (OPG) protein expression in periodontitis. J Periodontal Res. 2003 Aug;38(4):380-7. — View Citation

Dereka XE, Markopoulou CE, Fanourakis G, Tseleni-Balafouta S, Vrotsos IA. RANKL and OPG mRNA level after non-surgical periodontal treatment. Inflammation. 2010 Jun;33(3):200-6. doi: 10.1007/s10753-009-9174-7. — View Citation

Liu D, Xu JK, Figliomeni L, Huang L, Pavlos NJ, Rogers M, Tan A, Price P, Zheng MH. Expression of RANKL and OPG mRNA in periodontal disease: possible involvement in bone destruction. Int J Mol Med. 2003 Jan;11(1):17-21. — View Citation

Mogi M, Otogoto J, Ota N, Togari A. Differential expression of RANKL and osteoprotegerin in gingival crevicular fluid of patients with periodontitis. J Dent Res. 2004 Feb;83(2):166-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Osteoprotegerin levels at 3 and 6 months		Baseline, 3 months and 6 months	No
Secondary	changes from baseline in Clinical attachment level at 3 and 6 months.		Baseline, 3 months and 6 months	No
Secondary	Changes from baseline in probing pocket depth at 3 and 6 months		baseline, 3 months and 6 months	No
Secondary	Changes from baseline in plaque index at 3 and 6 months		baseline, 3 months and 6 months	No
Secondary	Changes from baseline in gingival index at 3 and 6 months		baseline, 3 months and 6 months	No