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NSPT on Calprotectin and Periostin Levels

Primary Purpose

Chronic Periodontitis, Cardiovascular Diseases, Periodontal Inflammation

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Non Surgical Periodontal Therapy
Sponsored by
Meenakshi Ammal Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Jaideep MahendraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Periodontitis without Cardiovascular disease

Periodontitis with cardiovascular disease

Arm Description

Periodontally and systemically healthy participants (Control group)

Periodontitis participants without cardiovascular disease

Periodontitis participants with cardiovascular disease

Outcomes

Primary Outcome Measures

Reduction in periodontal parameters
Reduction in Periodontal Probing Depth (measured in mm)
Reduction in periodontal variables
Reduction in Clinical Attachment Level (measured in mm)
Reduction in periodontal criteria
Reduction in Plaque Index (measured in numericals)
Reduction in periodontal variables
Reduction in Gingival index (mesured in numericals)

Secondary Outcome Measures

Full Information

First Posted
February 4, 2022
Last Updated
November 9, 2022
Sponsor
Meenakshi Ammal Dental College and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05618743
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meenakshi Ammal Dental College and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Cardiovascular Diseases, Periodontal Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three arm clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Periodontally and systemically healthy participants (Control group)
Arm Title
Periodontitis without Cardiovascular disease
Arm Type
Experimental
Arm Description
Periodontitis participants without cardiovascular disease
Arm Title
Periodontitis with cardiovascular disease
Arm Type
Experimental
Arm Description
Periodontitis participants with cardiovascular disease
Intervention Type
Procedure
Intervention Name(s)
Non Surgical Periodontal Therapy
Intervention Description
Scaling and root planing using scalers and periodontal curettes will be done
Primary Outcome Measure Information:
Title
Reduction in periodontal parameters
Description
Reduction in Periodontal Probing Depth (measured in mm)
Time Frame
Two years
Title
Reduction in periodontal variables
Description
Reduction in Clinical Attachment Level (measured in mm)
Time Frame
Two years
Title
Reduction in periodontal criteria
Description
Reduction in Plaque Index (measured in numericals)
Time Frame
Two years
Title
Reduction in periodontal variables
Description
Reduction in Gingival index (mesured in numericals)
Time Frame
Two years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only male participants are included belonging to 30-65 years of age
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaideep Mahendra, MDS, PhD
Phone
09444963973
Email
jaideep_m_23@yahoo.co.in
First Name & Middle Initial & Last Name or Official Title & Degree
Janani Muralidharan, BDS
Phone
08939394241
Email
janani.harini718@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaideep Mahendra, MDS,PhD
Organizational Affiliation
Meenakshi Ammal Dental College and Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaideep Mahendra
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600095
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaideep Mahendra, MDS;PhD
Phone
9444963973
Ext
9444963973
Email
jaideep_m_23@yahoo.co.in
First Name & Middle Initial & Last Name & Degree
Janani Muralidharan, BDS
Phone
8939394241
Email
janani.harini718@gmail.com
First Name & Middle Initial & Last Name & Degree
Janani Muralidharan, BDS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21488873
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.
Results Reference
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PubMed Identifier
33012041
Citation
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.
Results Reference
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NSPT on Calprotectin and Periostin Levels

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