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Osteoprotegerin Before and After Periodontal Surgery

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ClinicalTrials.gov Identifier: NCT02160613
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):
Noha Ayman Ghallab, Cairo University

Brief Summary:

The study hypothesis:

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


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Open flap debridement Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Effect of Periodontal Surgery on Osteoprotegerin Levels in Gingival Crevicular Fluid, Saliva and Gingival Tissues.
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Open flap for periodontitis patients
Open flap debridement
Procedure: Open flap debridement
an access flap




Primary Outcome Measures :
  1. Change from baseline in Osteoprotegerin levels at 3 and 6 months [ Time Frame: Baseline, 3 months and 6 months ]

Secondary Outcome Measures :
  1. changes from baseline in Clinical attachment level at 3 and 6 months. [ Time Frame: Baseline, 3 months and 6 months ]
  2. Changes from baseline in probing pocket depth at 3 and 6 months [ Time Frame: baseline, 3 months and 6 months ]
  3. Changes from baseline in plaque index at 3 and 6 months [ Time Frame: baseline, 3 months and 6 months ]
  4. Changes from baseline in gingival index at 3 and 6 months [ Time Frame: baseline, 3 months and 6 months ]


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Ages Eligible for Study:   32 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160613


Locations
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Egypt
Faculty of oral and dental medicine
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Mahmoud ElRefai, M.D. Professor of Oral Medicine and Periodontology , Faculty of oral and dental medicine Cairo Unv.
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Noha Ayman Ghallab, Associate Professor of periodontology, faculty of oral and dental medicine, Cairo University
ClinicalTrials.gov Identifier: NCT02160613    
Other Study ID Numbers: OPG_OFD
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014
Keywords provided by Noha Ayman Ghallab, Cairo University:
Osteoprotegerin
Biomarker
Chronic periodontitis
Open flap debridement
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases