NSPT on Calprotectin and Periostin Levels

NCT05618743 | Unknown

• 1 other identifier: MADC/IEC-I/023/2021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Reduction in periodontal parameters

  Reduction in Periodontal Probing Depth (measured in mm)

  Two years

• Reduction in periodontal variables

  Reduction in Clinical Attachment Level (measured in mm)

  Two years

• Reduction in periodontal criteria

  Reduction in Plaque Index (measured in numericals)

  Two years

• Reduction in periodontal variables

  Reduction in Gingival index (mesured in numericals)

  Two years

Study Arms (3)

Control Group

NO INTERVENTION

Periodontally and systemically healthy participants (Control group)

Periodontitis without Cardiovascular disease

EXPERIMENTAL

Periodontitis participants without cardiovascular disease

Procedure: Non Surgical Periodontal Therapy

Periodontitis with cardiovascular disease

EXPERIMENTAL

Periodontitis participants with cardiovascular disease

Procedure: Non Surgical Periodontal Therapy

Interventions

Non Surgical Periodontal Therapy PROCEDURE

Scaling and root planing using scalers and periodontal curettes will be done

Periodontitis with cardiovascular disease; Periodontitis without Cardiovascular disease

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Only male participants are included belonging to 30-65 years of age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Study Sites (1)

Jaideep Mahendra

Chennai, Tamil Nadu, 600095, India

RECRUITING

Related Publications (2)

• 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.

  PMID: 21488873 BACKGROUND

• 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.

  PMID: 33012041 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaideep Mahendra, MDS,PhD

  Meenakshi Ammal Dental College and Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaideep Mahendra, MDS, PhD

CONTACT

09444963973; jaideep_m_23@yahoo.co.in

Janani Muralidharan, BDS

CONTACT

08939394241; janani.harini718@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Post Graduate Studies, Professor, Department of Periodontics

Model Details: Three arm clinical trial

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: November 16, 2022
• Study Start: June 30, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)