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.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion criteria: - Patients of Syrian descent - Systemically healthy - Have at least 20 teeth Exclusion criteria: - Periodontal treatment during the last three months, - History of major systemic diseases - Consumption of anti oxidant supplements, antibiotics, anti inflammatory or any other drugs in the last three months - Smoking - Alcohol consumption - Pregnant and lactating women. |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Department of Periodontics, University of Damascus Dental School | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Abou Sulaiman AE, Shehadeh RM. Assessment of total antioxidant capacity and the use of vitamin C in the treatment of non-smokers with chronic periodontitis. J Periodontol. 2010 Nov;81(11):1547-54. doi: 10.1902/jop.2010.100173. Epub 2010 Jun 22. — View Citation
Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. Review. — View Citation
Chapple IL, Matthews JB. The role of reactive oxygen and antioxidant species in periodontal tissue destruction. Periodontol 2000. 2007;43:160-232. Review. — View Citation
Halliwell B. Reactive oxygen species in living systems: source, biochemistry, and role in human disease. Am J Med. 1991 Sep 30;91(3C):14S-22S. Review. — View Citation
Kinane DF. Causation and pathogenesis of periodontal disease. Periodontol 2000. 2001;25:8-20. Review. — View Citation
Sies H. Oxidative stress: oxidants and antioxidants. Exp Physiol. 1997 Mar;82(2):291-5. Review. — View Citation
Wactawski-Wende J. Periodontal diseases and osteoporosis: association and mechanisms. Ann Periodontol. 2001 Dec;6(1):197-208. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nitric oxide levels in serum and gingival cervicular fluid | Griess reagent to assess nitric oxide levels as a marker of nitrosative stress. | Within 24 hours after the collection of the serum and gingival fluid | No |
Primary | Malondialdihyide levels in serum and gingival cervicular fluid | TBARS assay (HPLC) will be used to assess the malondialdihyde levels as a marker of oxidative stress. | Within 24 hours after the collection of the serum and gingival fluid | No |
Secondary | Bleeding on Probing (BOP) | 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) | One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision | No |
Secondary | Plaque Index (PI) | A standard periodontal probe will be used for recording periodontal indices at six sites per tooth. | One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision | No |
Secondary | Clinical Attachment Loss (CAL) | A standard periodontal probe will be used for recording periodontal indices at six sites per tooth. | One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision | No |
Secondary | Periodontal Pocket Depth (PPD) | A standard periodontal probe will be used for recording periodontal indices at six sites per tooth. | One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision | No |
Secondary | Gingival Index (GI). | A standard periodontal probe will be used for recording periodontal indices at six sites per tooth. | One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision | No |
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