Serum Lipid Levels and Lp-PLA2 in Chronic Periodontitis

February 1, 2017 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

The Association Between Periodontal Status, Serum Lipid Levels and Lipoprotein Associated Lipophosphase A2(Lp-PLA2) in Chronic Periodontitis Subjects and Healthy Controls: A Case Control Study

To assess the association between periodontal parameters, serum lipid profile and Lp-PLA2 level in systemically healthy Chronic Periodontitis subjects and healthy controls.

Study Overview

Status

Completed

Detailed Description

Seventy five participants were divided into 3 groups. The groups consisted of GROUP I- generalized severe chronic periodontitis, GROUP II- generalized moderate chronic periodontitis and GROUP III- systemically and periodontally healthy volunteers who served as control. The selected patients were then evaluated for periodontal parameters, lipid profile and Lp-PLA2.

Study Type

Observational

Enrollment (Actual)

75

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population was selected from the Department of Periodontology, Meenakshi Ammal Dental College

Description

Inclusion Criteria:

Group I:

  1. Subjects with age ≥ 35 years.
  2. Presence of at least 24 teeth, with Clinical attachment loss (CAL) ≥ 5mm in more than 30% of sites.

Group II:

  1. Subjects with age ≥ 35 years.
  2. Presence of at least 24 teeth, with Clinical attachment loss (CAL) between 3-4 mm in more than 30% of sites.

Group III:

  1. Subjects with age ≥ 35 years.
  2. Healthy and intact periodontium

Exclusion Criteria:

  1. Presence of any systemic disease or conditions that could affect periodontal tissues.
  2. History of periodontal treatment in past 6 months.
  3. Smoking and alcoholism
  4. Anomalies of blood and immune system
  5. Systemic medication or antibiotic treatment for the previous 6 months.
  6. Pregnant females.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GROUP I
Estimation of serum lipid levels and Lp-PLA2 in generalized severe chronic periodontitis
Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis
Other Names:
  • Biological marker
GROUP II
Estimation of serum lipid levels and Lp-PLA2 in generalized moderate chronic periodontitis
Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis
Other Names:
  • Biological marker
GROUP III
Estimation of serum lipid levels and Lp-PLA2 in systemically and periodontally healthy controls
Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis
Other Names:
  • Biological marker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of serum Lp-PLA2
Time Frame: 9 months
Serum Lp-PLA2 was estimated in all the groups using ELISA
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of serum lipid profile
Time Frame: 9 months
Serum Total cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein and very low density lipoprotein
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bittu Koshy, BDS, Meenakshi Ammal Dental College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2015

Primary Completion (Actual)

August 23, 2015

Study Completion (Actual)

November 26, 2015

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • MADC/IRB/2015/91

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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