NSPT on Calprotectin and Periostin Levels

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618743
• Other study ID #: MADC/IEC-I/023/2021
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: Jaideep Mahendra, MDS, PhD
• Phone: 09444963973
• Email: jaideep_m_23[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Periodontitis
• Inflammation
• Periodontal Inflammation
• Periodontitis

Intervention

Procedure:
• Non Surgical Periodontal Therapy
Scaling and root planing using scalers and periodontal curettes will be done

Locations

Country	Name	City	State
India	Jaideep Mahendra	Chennai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

Country where clinical trial is conducted

India, 

References & Publications (2)

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

Outcome

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