NCT03041480

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

February 1, 2017

Last Update Submit

February 1, 2017

Conditions

Keywords

chronic periodontitislipidsLp-PLA2

Outcome Measures

Primary Outcomes (1)

  • Estimation of serum Lp-PLA2

    Serum Lp-PLA2 was estimated in all the groups using ELISA

    9 months

Secondary Outcomes (1)

  • Estimation of serum lipid profile

    9 months

Study Arms (3)

GROUP I

Estimation of serum lipid levels and Lp-PLA2 in generalized severe chronic periodontitis

Diagnostic Test: serum lipid levels and Lp-PLA2

GROUP II

Estimation of serum lipid levels and Lp-PLA2 in generalized moderate chronic periodontitis

Diagnostic Test: serum lipid levels and Lp-PLA2

GROUP III

Estimation of serum lipid levels and Lp-PLA2 in systemically and periodontally healthy controls

Diagnostic Test: serum lipid levels and Lp-PLA2

Interventions

Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis

Also known as: Biological marker
GROUP IGROUP IIGROUP III

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22866279BACKGROUND
  • 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.

    PMID: 20809860BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bittu Koshy, BDS

    Meenakshi Ammal Dental College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 2, 2017

Study Start

February 2, 2015

Primary Completion

August 23, 2015

Study Completion

November 26, 2015

Last Updated

February 2, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share