Clinical Trial: Nitro-oxidative Stress in Periodontitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Assessment of Nitro - Oxidative Stress in Periodontal Disease

Brief Summary:

Periodontitis is a chronic inflammatory disease whose etio-pathogencity is not fully understood yet. Reactive oxygen species (ROS) and reactive nitrogen species (RNS) are involved in physiological and pathological processes. Nitro-oxidative stress has been implicated in Periodontitis.

The aim of this study is to assess the levels of ROS and RNS in serum and gingival crevicular fluid (GCF) samples taken from periodontitis (chronic and aggressive) patients and healthy controls. Subsequently, correlating these levels with the severity of periodontal disease.

Eighty subjects will be invited to participate in this study. Patients will be allocated into four groups (20 patients each). The biochemical parameters that will be investigated are Malondialdehyde (MDA) (using TBRSA assay) as a marker of oxidative stress and (NO- level using Griess reagent) as a marker of nitrosative stress.


Detailed Summary:

Introduction:

Teeth and their supporting periodontal structures are of great importance in good oral health. Periodontitis is an inflammatory disease of the periodontium which affects the supporting tissues of the teeth. The disease is multifaceted and its etio-pathogenecity is still not fully understood and therefore the treatment of different types of periodontal disease can be very difficult. Numerous risk factors have been implicated in the disease process including risk determinants and risk indicators. Most recently, strong body of evidence has accumulated to support a role for reactive oxygen (ROS) and nitrogen species (RNS) either as trigger agents or more frequently, aggravators of the primary lesions in periodontitis.

Oxygen and nitrogen reactive species are involved in a large number of physiological and pathological processes. ROS generated by monocytes and neutrophyles during inflammation are important aggression factors in the periodontal tissues. ROS play an important role in activation of osteoclasts and in bone resorption.

Oxidative stress is a condition arising when there is a serious imbalance between the levels of free radicals in a cell and its antioxidant defenses in favor of the former. Thus, tissue damage can result when antioxidant systems are unable to counteract the free radicals actions efficiently. Inflammation when stimulated by bacterial pathogens, host cells release proinflammatory cytokines (IL-1α, IL-6, IL-8, and tumor necrosis factor-α) as part of immune response. These cytokines recruit polymorphonuclear cells (PMNs) that play a major role in the etiology of periodontal disease by producing proteolytic enzymes, such as elastase and O2 (molecular oxygen) by the oxidative burst.

In
Sponsor: Damascus University

Current Primary Outcome:

  • Nitric oxide levels in serum and gingival cervicular fluid [ Time Frame: Within 24 hours after the collection of the serum and gingival fluid ]
    Griess reagent to assess nitric oxide levels as a marker of nitrosative stress.
  • Malondialdihyide levels in serum and gingival cervicular fluid [ Time Frame: Within 24 hours after the collection of the serum and gingival fluid ]
    TBARS assay (HPLC) will be used to assess the malondialdihyde levels as a marker of oxidative stress.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bleeding on Probing (BOP) [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth. The examined clinical parameters include bleeding on probing (BOP)
  • Plaque Index (PI) [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.
  • Clinical Attachment Loss (CAL) [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.
  • Periodontal Pocket Depth (PPD) [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.
  • Gingival Index (GI). [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.


Original Secondary Outcome: Same as current

Information By: Damascus University

Dates:
Date Received: April 25, 2014
Date Started: May 2014
Date Completion:
Last Updated: October 2, 2015
Last Verified: October 2015