Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. The emerging era of molecular analysis has paved the way to quantify and study the disease markers to which plays a vital role in disease progression. This, in turn, has marked the advent of various studies which employ the use of serum, saliva, gingival crevicular fluid, plaque and tissue samples, etc., to study various diseases in the oral cavity and its relation with systemic diseases. Several epidemiological studies support an association between high levels of inflammatory biomarkers due to periodontal infections and increased risk and progression of cardio vascular disease. Both periodontitis and cardio vascular disease share various biomarkers expressed in common present in saliva, serum and gingival crevicular fluid which correlates the link of periodontitis with cardiovascular disease. 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. Calprotectin have been detected in GCF and oral tissues where in initial periodontal therapy can reduce the levels of Calprotectin, but their clinical significance has never been investigated in patients with chronic periodontitis and cardiovascular disease. Among the various matricellular proteins expressed in saliva and GCF, Periostin is a marked anti-inflammatory protein belonging to fascilin family which actively contributed to tissue injury, fibrosis, atherosclerosis and inflammatory diseases. Periostin is commonly found in collagen rich tissues thereby it is thought to affect the production of collagen fibrils. The defensive role of Periostin in periodontal tissues and its expression in periodontitis and cardio vascular disease correlating with before and after non-surgical therapy is less studied which on further exploration might be a potent risk assessment tool linking periodontal and cardiovascular diseases. While there are studies which have demonstrated the expression of Calprotectin and Periostin in gingival crevicular fluid (GCF) of periodontal patients separately, there are no studies which correlate their interrelationship in periodontitis and cardiovascular disease. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05618743
Study type Interventional
Source Meenakshi Ammal Dental College and Hospital
Contact Jaideep Mahendra, MDS, PhD
Phone 09444963973
Email jaideep_m_23@yahoo.co.in
Status Recruiting
Phase N/A
Start date June 30, 2021
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06211361 - Cardiac Rehabilitation Program in Patients With Cardiovascular Disease N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)