Chronic Periodontitis Clinical Trial
Official title:
Assessment of Nitro - Oxidative Stress in Periodontal Disease
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.
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 a recent study, Abou Sulaiman & Shehadeh found that serum total antioxidant capacity
(TAS) was lower in non-smokers Syrian patients with chronic periodontitis compared to
healthy controls. Also, they reported that periodontal treatment restored TAS levels to
normal levels similar to healthy controls.
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 patients (chronic and aggressive)
and healthy controls. Subsequently, correlating these levels with severity of periodontal
disease in Syrian patients.
Materials and methods:
A total of 80 subjects will be invited to participate in this study from the patients
referred to the Department of Periodontology, Faculty of Dentistry, University of Damascus.
The study has been approved by our local Review Board. Subjects will be recruited according
to specific inclusion criteria after completion of medical and dental history
questionnaires. Patients will sign a consent form after being advised about the nature of
the study.
The selection of patients will be made according of the criteria approved by the 1999
international world workshop for a classification system of periodontal diseases and
conditions using five clinical parameters and full mouth or panoramic radiographs for
diagnosis.
Subjects will be allocated into four groups:
- Chronic Periodontitis group (ChP): comprise 20 patients aged > 45 years and have
presence of ≥2 non-adjacent sites per quadrant that were not first molars or incisors,
with probing depth (PD) ≥5 mm, which bleed on gentle probing. The demonstrated
radiographic bone loss ≥30% of the root length, patient with poor oral hygiene, the
amount of accumulated plaque commensurate with the amount of clinical attachment level
(CAL)
- Resistant Control group (R): comprise 20 age-sex matched patients who are > 45 years
exhibit no signs of periodontal disease as determined by the absence of the evidence of
interproximal (CAL ≤ 1mm), PD > 3 mm at any site, whole-mouth bleeding scores <10% and
have no clinical signs of gingival inflammation .
- Aggressive Periodontitis group (AgP): comprise 20 patients who are aged < 35 years and
diagnosed with rapid attachment loss with periodontal pocket depth (PD) > 4 mm around
at least three teeth other than the first molars and incisors. Rapid bone destruction
(>50%bone loss at diseased sites). Weak relationship between dental plaque and the
severity of gingival inflammation.
- Young Control group (YC): comprise 20 age- and sex matched patients who are < 35 years
and exhibit no signs of periodontal disease.
Clinical measurements:
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), clinical attachment loss (CAL) and periodontal pocket depth (PPD) and gingival index
(GI).
Collection of samples
Subjects will be asked to refrain from brushing within 1 hour of sampling. (GCF) samples
will be obtained using standard paper strips (Periocol strips, Oraflow, NY, USA). 6 samples
from each individual (mesiofacial, distopalatal) sites from each examined tooth (incisor,
premolar and molar) in the maxilla (Chapple et al. 2002). Strips will be put in PBS Buffer
solution for 30 minutes then extracted and stored under liquid nitrogen.
Venous blood samples will be collected from the antecubital fossa and stored in lithium
heparin tubes and allowed to stand for 30 minutes before being centrifuged at 1000 ×g for 30
minutes, samples will be aliquoted into cryogenic vials and will be stored under liquid
nitrogen.
Laboratory studies:
- TBARS assay (HPLC) will be used to assess the malondialdihyde levels as a marker of
oxidative stress.
- Griess reagent to assess nitric oxide levels as a marker of nitrosative stress.
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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