Osteoprotegerin Before and After Periodontal Surgery

June 7, 2014 updated by: Noha Ayman Ghallab, Cairo University

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

The study hypothesis:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Oral and Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open flap for periodontitis patients
Open flap debridement
Procedure: Open flap debridement
an access flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Osteoprotegerin levels at 3 and 6 months
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
changes from baseline in Clinical attachment level at 3 and 6 months.
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months
Changes from baseline in probing pocket depth at 3 and 6 months
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
Changes from baseline in plaque index at 3 and 6 months
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
Changes from baseline in gingival index at 3 and 6 months
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Mahmoud ElRefai, M.D., Professor of Oral Medicine and Periodontology , Faculty of oral and dental medicine Cairo Unv.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

June 7, 2014

First Submitted That Met QC Criteria

June 7, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 7, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPG_OFD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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