Clinical trial NCT02160613: Osteoprotegerin Before and After Periodontal Surgery
Official title: Effect of Periodontal Surgery on Osteoprotegerin Levels in Gingival Crevicular Fluid, Saliva and Gingival Tissues.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: Osteoprotegerin
Biomarker
Chronic periodontitis
Open flap debridement
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 32
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study hypothesis:

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Osteoprotegerin levels at 3 and 6 months
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: changes from baseline in Clinical attachment level at 3 and 6 months.
timeFrame: Baseline, 3 months and 6 months
measure: Changes from baseline in probing pocket depth at 3 and 6 months
timeFrame: baseline, 3 months and 6 months
measure: Changes from baseline in plaque index at 3 and 6 months
timeFrame: baseline, 3 months and 6 months
measure: Changes from baseline in gingival index at 3 and 6 months
timeFrame: baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral and dental medicine
Study officials:
affiliation: Professor of Oral Medicine and Periodontology , Faculty of oral and dental medicine Cairo Unv.
name: Mahmoud ElRefai, M.D.
role: STUDY_DIRECTOR
References:
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. doi: 10.3892/ijmm.11.1.17.
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. doi: 10.1034/j.1600-0765.2003.00615.x.
citation: Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Toz 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 Periodontal Res. 2007 Aug;42(4):287-93. doi: 10.1111/j.1600-0765.2006.00946.x.
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. doi: 10.1177/154405910408300216.
citation: Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Toz 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. doi: 10.1111/j.1600-051X.2007.01061.x. Epub 2007 Mar 13.
citation: Buduneli N, Buduneli E, Kutukculer 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):1274-80. doi: 10.1902/jop.2009.090106.
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: 10.1902/jop.2009.090510.
citation: Bostanci N, Saygan B, Emingil G, Atilla G, Belibasakis GN. Effect of periodontal treatment on receptor activator of NF-kappaB ligand and osteoprotegerin levels and relative ratio in gingival crevicular fluid. J Clin Periodontol. 2011 May;38(5):428-33. doi: 10.1111/j.1600-051X.2011.01701.x. Epub 2011 Jan 24.
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.
citation: Hassan SH, El-Refai MI, Ghallab NA, Kasem RF, Shaker OG. Effect of periodontal surgery on osteoprotegerin levels in gingival crevicular fluid, saliva, and gingival tissues of chronic periodontitis patients. Dis Markers. 2015;2015:341259. doi: 10.1155/2015/341259. Epub 2015 Feb 28.