Serum Lipid Levels and Lp-PLA2 in Chronic Periodontitis

Chronic Periodontitis (Disorder) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041480
• Other study ID #: MADC/IRB/2015/91
• Status: Completed
• Phase: N/A
• First received: February 1, 2017
• Last updated: February 1, 2017
• Start date: February 2, 2015
• Est. completion date: November 26, 2015

Study information

• Verified date: January 2017
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 26, 2015
• Est. primary completion date: August 23, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Chronic Periodontitis (Disorder)
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

References & Publications (2)

Fentoglu O, Köroglu BK, Kara Y, Dogan B, Yilmaz G, Sütçü R, Ay ZY, Tonguç MÖ, Orhan H, Tamer MN, Kirzioglu FY. Serum lipoprotein-associated phospholipase A2 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of serum Lp-PLA2	Serum Lp-PLA2 was estimated in all the groups using ELISA	9 months
Secondary	Estimation of serum lipid profile	Serum Total cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein and very low density lipoprotein	9 months