Osteoprotegerin Before and After Periodontal Surgery

NCT02160613 | Completed DMC

• 1 other identifier: OPG_OFD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis: Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?

Conditions

Chronic Periodontitis

Keywords

Osteoprotegerin; Biomarker; Chronic periodontitis; Open flap debridement

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Osteoprotegerin levels at 3 and 6 months

  Baseline, 3 months and 6 months

Secondary Outcomes (4)

• changes from baseline in Clinical attachment level at 3 and 6 months.

  Baseline, 3 months and 6 months

• Changes from baseline in probing pocket depth at 3 and 6 months

  baseline, 3 months and 6 months

• Changes from baseline in plaque index at 3 and 6 months

  baseline, 3 months and 6 months

• Changes from baseline in gingival index at 3 and 6 months

  baseline, 3 months and 6 months

Study Arms (1)

Open flap for periodontitis patients

OTHER

Open flap debridement

Procedure: Open flap debridement

Interventions

Open flap debridement PROCEDURE

an access flap

Open flap for periodontitis patients

Eligibility Criteria

• Age: 32 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral and dental medicine

Cairo, Egypt

Location

Related Publications (10)

• 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.

  PMID: 12469211 RESULT

• 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.

  PMID: 12828654 RESULT

• 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.

  PMID: 17559623 RESULT

• 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.

  PMID: 14742657 RESULT

• 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.

  PMID: 17355365 RESULT

• 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.

  PMID: 19656027 RESULT

• 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.

  PMID: 20192865 RESULT

• 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.

  PMID: 21261673 RESULT

• 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.

  PMID: 20033478 RESULT

• 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.

  PMID: 25814780 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahmoud ElRefai, M.D.

  Professor of Oral Medicine and Periodontology , Faculty of oral and dental medicine Cairo Unv.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of periodontology, faculty of oral and dental medicine

Study Record Dates

• First Submitted: June 7, 2014
• First Posted: June 10, 2014
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

EG (1)