- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03041480
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
Conditions
Intervention / Treatment
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:
- Subjects with age ≥ 35 years.
- Presence of at least 24 teeth, with Clinical attachment loss (CAL) ≥ 5mm in more than 30% of sites.
Group II:
- Subjects with age ≥ 35 years.
- Presence of at least 24 teeth, with Clinical attachment loss (CAL) between 3-4 mm in more than 30% of sites.
Group III:
- Subjects with age ≥ 35 years.
- Healthy and intact periodontium
Exclusion Criteria:
- Presence of any systemic disease or conditions that could affect periodontal tissues.
- History of periodontal treatment in past 6 months.
- Smoking and alcoholism
- Anomalies of blood and immune system
- Systemic medication or antibiotic treatment for the previous 6 months.
- 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:
|
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:
|
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:
|
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.
General Publications
- Zhou SY, Xiao WM, Ouyang XY. Lipoprotein-associated phospholipase A2 and serum lipid levels in subjects with chronic periodontitis and hyperlipidemia. Chin J Dent Res. 2012;15(1):25-9.
- Fentoglu O, Koroglu BK, Kara Y, Dogan B, Yilmaz G, Sutcu R, Ay ZY, Tonguc MO, Orhan H, Tamer MN, Kirzioglu FY. Serum lipoprotein-associated phospholipase A(2) and C-reactive protein levels in association with periodontal disease and hyperlipidemia. J Periodontol. 2011 Mar;82(3):350-9. doi: 10.1902/jop.2010.100417. Epub 2010 Sep 1.
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
Keywords
Additional Relevant MeSH Terms
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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