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Osteoprotegerin Before and After Periodontal Surgery

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Open flap debridement
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Periodontitis focused on measuring Osteoprotegerin, Biomarker, Chronic periodontitis, Open flap debridement

Eligibility Criteria

32 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of oral and dental medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open flap for periodontitis patients

Arm Description

Open flap debridement

Outcomes

Primary Outcome Measures

Change from baseline in Osteoprotegerin levels at 3 and 6 months

Secondary Outcome Measures

changes from baseline in Clinical attachment level at 3 and 6 months.
Changes from baseline in probing pocket depth at 3 and 6 months
Changes from baseline in plaque index at 3 and 6 months
Changes from baseline in gingival index at 3 and 6 months

Full Information

First Posted
June 7, 2014
Last Updated
June 7, 2014
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02160613
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Osteoprotegerin, Biomarker, Chronic periodontitis, Open flap debridement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open flap for periodontitis patients
Arm Type
Other
Arm Description
Open flap debridement
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement
Intervention Description
an access flap
Primary Outcome Measure Information:
Title
Change from baseline in Osteoprotegerin levels at 3 and 6 months
Time Frame
Baseline, 3 months and 6 months
Secondary Outcome Measure Information:
Title
changes from baseline in Clinical attachment level at 3 and 6 months.
Time Frame
Baseline, 3 months and 6 months
Title
Changes from baseline in probing pocket depth at 3 and 6 months
Time Frame
baseline, 3 months and 6 months
Title
Changes from baseline in plaque index at 3 and 6 months
Time Frame
baseline, 3 months and 6 months
Title
Changes from baseline in gingival index at 3 and 6 months
Time Frame
baseline, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud ElRefai, M.D.
Organizational Affiliation
Professor of Oral Medicine and Periodontology , Faculty of oral and dental medicine Cairo Unv.
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of oral and dental medicine
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
12469211
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.
Results Reference
result
PubMed Identifier
12828654
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.
Results Reference
result
PubMed Identifier
17559623
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.
Results Reference
result
PubMed Identifier
14742657
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.
Results Reference
result
PubMed Identifier
17355365
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.
Results Reference
result
PubMed Identifier
19656027
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.
Results Reference
result
PubMed Identifier
20192865
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.
Results Reference
result
PubMed Identifier
21261673
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.
Results Reference
result
PubMed Identifier
20033478
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.
Results Reference
result
PubMed Identifier
25814780
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.
Results Reference
derived

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Osteoprotegerin Before and After Periodontal Surgery

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