Cardiovascular Diseases Clinical Trial
Official title:
Effect of Non Surgical Therapy on Calprotectin and Periostin Levels in Patients With Periodontitis and Cardiovascular Diseases - An Interventional Study
Periodontitis is a chronic inflammatory disease is initiated by the oral microbial biofilm where in the response to this infection is mediated by various intracellular signalling pathways leading to the production of numerous bio-molecules. . Calprotectin is major cytoplasmic protein expressed in majority by neutrophils and as well seen in gingival epithelial cells, activated macrophages and vascular endothelial cells in minor amounts. Calprotectin is regarded as acute phase protein that increases during a variety of inflammatory diseases like periodontitis, cardiovascular disease, diabetes, rheumatoid arthritis and inflammatory bowel disease. Periostin is a marked anti-inflammatory protein belonging to fascilin family which actively contributed to tissue injury, fibrosis, atherosclerosis and inflammatory diseases Hence this study aims to determine the expression of Calprotectin and Periostin as biomarkers and also as putative risk indicators in generalized chronic periodontitis subjects with or without cardiovascular disease before and after non-surgical therapy.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | December 31, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: • Patients willing to participate in the study. Patients within the age group of 30-65 years. Patients should have = 20 remaining natural teeth. For Group I Systemically healthy, Periodontally healthy subjects with Probing pocket depth (PD) less than 4mm, bleeding on probing (BOP) at =15% of tooth sites, no periodontal treatment (Scaling and root planing or periodontal surgery) within the previous 6 months and without evident clinical signs of gingival inflammation. . For Group II Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) = 2mm, radiographic evidence of alveolar crestal bone loss = 2mm from the cemento-enamel junction along with cardiovascular disease. For Group III Systemically healthy, Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) = 2mm, radiographic evidence of alveolar crestal bone loss = 2mm from the cemento-enamel junction. Exclusion Criteria: Subjects with systemic conditions such as type I and type II diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation. For Group III, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded. Current smokers and individuals who quit smoking less than 6 months. Patients who have undergone periodontal therapy within the previous 6 months. Pregnant women (pregnancy may alter the oral flora) |
Country | Name | City | State |
---|---|---|---|
India | Jaideep Mahendra | Chennai | Tamilnadu |
Lead Sponsor | Collaborator |
---|---|
Meenakshi Ammal Dental College and Hospital |
India,
Arslan R, Karsiyaka Hendek M, Kisa U, Olgun E. The effect of non-surgical periodontal treatment on gingival crevicular fluid periostin levels in patients with gingivitis and periodontitis. Oral Dis. 2021 Sep;27(6):1478-1486. doi: 10.1111/odi.13664. Epub 2020 Oct 23. — View Citation
Kaner D, Bernimoulin JP, Dietrich T, Kleber BM, Friedmann A. Calprotectin levels in gingival crevicular fluid predict disease activity in patients treated for generalized aggressive periodontitis. J Periodontal Res. 2011 Aug;46(4):417-26. doi: 10.1111/j.1600-0765.2011.01355.x. Epub 2011 Apr 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in periodontal parameters | Reduction in Periodontal Probing Depth (measured in mm) | Two years | |
Primary | Reduction in periodontal variables | Reduction in Clinical Attachment Level (measured in mm) | Two years | |
Primary | Reduction in periodontal criteria | Reduction in Plaque Index (measured in numericals) | Two years | |
Primary | Reduction in periodontal variables | Reduction in Gingival index (mesured in numericals) | Two years |
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