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Trial record 20 of 312 for:    "Periodontitis, Chronic"

Serum Lipid Levels and Lp-PLA2 in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT03041480
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

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

Condition or disease Intervention/treatment
Chronic Periodontitis (Disorder) Diagnostic Test: serum lipid levels and Lp-PLA2

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.

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: 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
Actual Study Start Date : February 2, 2015
Actual Primary Completion Date : August 23, 2015
Actual Study Completion Date : November 26, 2015

Group/Cohort Intervention/treatment
GROUP I
Estimation of serum lipid levels and Lp-PLA2 in generalized severe chronic periodontitis
Diagnostic Test: serum lipid levels and Lp-PLA2
Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis
Other Name: Biological marker

GROUP II
Estimation of serum lipid levels and Lp-PLA2 in generalized moderate chronic periodontitis
Diagnostic Test: serum lipid levels and Lp-PLA2
Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis
Other Name: Biological marker

GROUP III
Estimation of serum lipid levels and Lp-PLA2 in systemically and periodontally healthy controls
Diagnostic Test: serum lipid levels and Lp-PLA2
Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis
Other Name: Biological marker




Primary Outcome Measures :
  1. Estimation of serum Lp-PLA2 [ Time Frame: 9 months ]
    Serum Lp-PLA2 was estimated in all the groups using ELISA


Secondary Outcome Measures :
  1. Estimation of serum lipid profile [ Time Frame: 9 months ]
    Serum Total cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein and very low density lipoprotein



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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population was selected from the Department of Periodontology, Meenakshi Ammal Dental College
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041480


Sponsors and Collaborators
Meenakshi Ammal Dental College and Hospital
Investigators
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Principal Investigator: Bittu Koshy, BDS Meenakshi Ammal Dental College

Publications:
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Responsible Party: Dr.Jaideep Mahendra, Professor, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier: NCT03041480     History of Changes
Other Study ID Numbers: MADC/IRB/2015/91
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital:
chronic periodontitis
lipids
Lp-PLA2

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases