Chronic Periodontitis (Disorder)NCT03041480

Serum Lipid Levels and Lp-PLA2 in Chronic Periodontitis

An observational study of Chronic Periodontitis (Disorder), run by Meenakshi Ammal Dental College and Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 35 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Periodontitis (Disorder)
What is being tested?: serum lipid levels and Lp-PLA2
How many people: 75 participants
Where: No sites listed yet
Study dates: 2 Feb 2015to 26 Nov 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 64 years
All sexes
Healthy volunteers accepted
Adult

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

Who may be able to join

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.

Show all 9Show fewer

Group III:
Subjects with age ≥ 35 years.
Healthy and intact periodontium

Who cannot join

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.

About this study

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

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

Read the 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.

Conditions: Chronic Periodontitis (Disorder)
Being tested: serum lipid levels and Lp-PLA2
Keywords: chronic periodontitis, lipids, Lp-PLA2
Medical subject headings: Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

serum lipid levels and Lp-PLA2Diagnostic test
Also called Biological marker
Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis

Study groups in NCT03041480
Study group	Role	What they receive
GROUP I		Estimation of serum lipid levels and Lp-PLA2 in generalized severe chronic periodontitis Receives: Diagnostic Test: serum lipid levels and Lp-PLA2
GROUP II		Estimation of serum lipid levels and Lp-PLA2 in generalized moderate chronic periodontitis Receives: Diagnostic Test: serum lipid levels and Lp-PLA2
GROUP III		Estimation of serum lipid levels and Lp-PLA2 in systemically and periodontally healthy controls Receives: Diagnostic Test: serum lipid levels and Lp-PLA2

What is being measured

The primary outcome is the main question the study is designed to answer.

Estimation of serum Lp-PLA2
Serum Lp-PLA2 was estimated in all the groups using ELISA
Measured: 9 months

Secondary outcomes (1)

Estimation of serum lipid profile
Serum Total cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein and very low density lipoprotein
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 201526 Nov 2015

First posted2 Feb 2017 (estimated)
Study start2 Feb 2015
Primary completion23 Aug 2015
Study completion26 Nov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Periodontitis (Disorder)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Other
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03041480
Sponsor's protocol ID: MADC/IRB/2015/91
Status last verified: Jan 2017
First submitted: 1 Feb 2017
Last updated: 2 Feb 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 22866279
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.
PubMed 20809860

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
Not yet recruitingObservational study
Evaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis.
Periodontitis, Adult, Periodontitis

All Chronic Periodontitis (Disorder) trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03041480
Acronym / sponsor ID: MADC/IRB/2015/91
Conditions: Chronic Periodontitis (Disorder)
Keywords: chronic periodontitis, lipids, Lp-PLA2
Study type: Observational
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
Study start: 2 Feb 2015 (actual)
Primary completion: 23 Aug 2015 (actual)
Study completion: 26 Nov 2015 (actual)
First posted: 2 Feb 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Case-control
Time perspective: Other
Number of arms: 3

Arm	Type	Receives
GROUP I	–	Diagnostic Test: serum lipid levels and Lp-PLA2Estimation of serum lipid levels and Lp-PLA2 in generalized severe chronic periodontitis
GROUP II	–	Diagnostic Test: serum lipid levels and Lp-PLA2Estimation of serum lipid levels and Lp-PLA2 in generalized moderate chronic periodontitis
GROUP III	–	Diagnostic Test: serum lipid levels and Lp-PLA2Estimation of serum lipid levels and Lp-PLA2 in systemically and periodontally healthy controls

Who may qualify

Ages: 35 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: The study population was selected from the Department of Periodontology, Meenakshi Ammal Dental College

Key inclusion criteria (9 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
serum lipid levels and Lp-PLA2Also: Biological markerEstimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis	Diagnostic test	GROUP I, GROUP II, GROUP III

Primary outcome

Estimation of serum Lp-PLA2
Time frame: 9 months
Serum Lp-PLA2 was estimated in all the groups using ELISA

1 secondary outcome

Estimation of serum lipid profile
Time frame: 9 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
Background: PubMed 22866279Zhou 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.
Background: PubMed 20809860Fentoglu 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.
Individual participant dataSharing planned: No

Related trials for Chronic Periodontitis (Disorder)

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
Not yet recruitingObservational study
Evaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis.
Periodontitis, Adult, Periodontitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bittu Koshy, BDS principal investigator

Meenakshi Ammal Dental College

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Periodontitis (Disorder), run by Meenakshi Ammal Dental College and Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimation of serum Lp-PLA2 (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03041480, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.