Interventional Recruiting
NCT05618743 on ClinicalTrials.gov
NSPT on Calprotectin and Periostin Levels
Official title: Effect of Non Surgical Therapy on Calprotectin and Periostin Levels in Patients With Periodontitis and Cardiovascular Diseases - An Interventional Study
- Sponsor: Meenakshi Ammal Dental College and Hospital
- Enrollment: 45 (Estimated)
- Study start: 2021-06-30 (Actual)
- Primary completion: 2022-11-30 (Estimated)
- Study completion: 2022-12-31 (Estimated)
- Allocation: Non-Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Three arm clinical trial
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
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.
Conditions
- Chronic Periodontitis
- Cardiovascular Diseases
- Periodontal Inflammation
Intervention / Treatment
- Procedure: Non Surgical Periodontal Therapy
Primary Outcome Measures
-
Reduction in periodontal parameters
(Two years)
Reduction in Periodontal Probing Depth (measured in mm) -
Reduction in periodontal variables
(Two years)
Reduction in Clinical Attachment Level (measured in mm) -
Reduction in periodontal criteria
(Two years)
Reduction in Plaque Index (measured in numericals) -
Reduction in periodontal variables
(Two years)
Reduction in Gingival index (mesured in numericals)
Countries
India
Locations and Investigators
-
Jaideep Mahendra, Chennai, India (Recruiting)
- Jaideep Mahendra, MDS;PhD
- Janani Muralidharan, BDS
- Janani Muralidharan, BDS (Principal Investigator)
Study Officials
- Jaideep Mahendra, MDS,PhD (Principal Investigator) — Meenakshi Ammal Dental College and Hospitals