An interventional study of Non Surgical Periodontal Therapy in Chronic Periodontitis, Cardiovascular Diseases and Periodontal Inflammation, sponsored by Meenakshi Ammal Dental College and Hospital. Status unknown at 1 site in India. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by Meenakshi Ammal Dental College and Hospital · Not applicable, Interventional, and Treatment
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.
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.
386 studies on the registry are indexed under Chronic Periodontitis; 23 are open to participants now.
This study's planned enrollment of 45 is close to the median of 46 across 314 interventional studies indexed under Chronic Periodontitis.
Browse Chronic Periodontitis studies →Meenakshi Ammal Dental College and Hospital is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
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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)
Periodontally and systemically healthy participants (Control group)
Periodontitis participants without cardiovascular disease
Procedure: Non Surgical Periodontal Therapy
Periodontitis participants with cardiovascular disease
Procedure: Non Surgical Periodontal Therapy
Scaling and root planing using scalers and periodontal curettes will be done
Reduction in periodontal parameters
Reduction in Periodontal Probing Depth (measured in mm)
Time frame: Two years
Reduction in periodontal variables
Reduction in Clinical Attachment Level (measured in mm)
Time frame: Two years
Reduction in periodontal criteria
Reduction in Plaque Index (measured in numericals)
Time frame: Two years
Reduction in periodontal variables
Reduction in Gingival index (mesured in numericals)
Time frame: Two years
Plan to share: No
Started Jun 2021 (actual). Primary completion is estimated for Nov 2022, 17 months after the start.
Of 84 non-industry interventional studies with no phase under Chronic Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's planned 17 months is above that.
Counting every sponsor, half of 87 studies reached it within 15 months; a quarter within 10 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Meenakshi Ammal Dental College and Hospital