Is There a Relationship Between Hyperlipidemia and Periodontitis?

July 5, 2016 updated by: Marmara University

The aim of present study is to investigate any relationship between hyperlipidemia and periodontal disease regarding the periodontal parameters and plasma lipid parameters, along with age, gender, brushing habit, body mass index, dietary habit, physical activity, alcohol consumption.

In this cross sectional study, a total of 160 individuals were divided into two groups based on their metabolic status: hyperlipidemic group (n=97) and normolipidemic group (n=63). Plaque index, gingival index, bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL) clinical parameters and community periodontal index of treatment needs (CPITN) scores were measured. Triglyceride (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C) levels had been determined previously during individuals routine systemic examinations. Daily brushing habits and interdental cleaning together with dietary habits, alcohol consumption and physical activity levels were also recorded.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A total of 240 subjects were examined among patients who attended to the Department of Periodontology, Marmara University or the Turkish Heart Foundation and had their plasma lipid values determined within the last 3 months. Out of 240, 160 subjects (57 male, 103 female, age range 35-65 years) eligible for this study were selected.

Description

Inclusion Criteria:

  • Subjects having no periodontal treatment within previous 6 months,
  • number of natural teeth ≥ 10,
  • no history of cancer and systemic disease that affects lipid levels or periodontium,
  • no history of medical treatment for hyperlipidemia, BMI< 30 kg/m2,
  • no pregnancy,
  • no history of systemic antibiotic treatment within previous 3 months,
  • no smoking.

Exclusion Criteria:

  • patients with history of systemic disease that affects lipid metabolism or periodontal disease
  • history of medical treatment for hyperlipidemia
  • pregnancy, lactation or hormone replacement therapy at the time of study
  • use of any other drug known to affect lipid metabolism or periodontal disease
  • systemic infection or any history of systemic antibiotic treatment in previous 3 months
  • smokers as well as ex-smokers

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: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HP+
Subjects with plasma Triglyceride or Total cholesterol levels > 200 mg/dl and low density lipoprotein-cholesterol levels > 130 mg/dl were included in the hyperlipidemic group and having periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels.
Other: No intervention was applied
No intervention was applied
HP-
Subjects with plasma Triglyceride or Total cholesterol levels > 200 mg/dl and low density lipoprotein-cholesterol levels > 130 mg/dl were included in the hyperlipidemic group and do not have periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels.
Other: No intervention was applied
No intervention was applied
NP+
Subjects with plasma Triglyceride or Total cholesterol levels < 200 mg/dl and low density lipoprotein-cholesterol levels < 130 mg/dl were included in the normolipidemic group and having periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels.
Other: No intervention was applied
No intervention was applied
NP-
Subjects with plasma Triglyceride or Total cholesterol levels < 200 mg/dl and low density lipoprotein-cholesterol levels < 130 mg/dl were included in the normolipidemic group and do not have periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels.
Other: No intervention was applied
No intervention was applied

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Triglyceride (TG)
Time Frame: day 0
Subjects with plasma TG or TC levels > 200 mg/dl and LDL-C levels > 130 mg/dl were included in the hyperlipidemic group, while the normolipidemic group comprised of patients with plasma TG or TC levels below the aforementioned limits
day 0
Total cholesterol (TC)
Time Frame: day 0
Subjects with plasma TG or TC levels > 200 mg/dl and LDL-C levels > 130 mg/dl were included in the hyperlipidemic group, while the normolipidemic group comprised of patients with plasma TG or TC levels below the aforementioned limits
day 0
Low density lipoprotein cholesterol (LDL-C)
Time Frame: day 0
Subjects with plasma TG or TC levels > 200 mg/dl and LDL-C levels > 130 mg/dl were included in the hyperlipidemic group, while the normolipidemic group comprised of patients with plasma TG or TC levels below the aforementioned limits
day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: day 0
The measurement of the state of oral hygiene based on recording dental plaque accumulation
day 0
Gingival index
Time Frame: day 0
An assessment level of gingival health and inflammation
day 0
Bleeding on probing
Time Frame: day 0
A sign of gingival inflammation were assessed on the buccal, lingual, mesial and distal sites of each tooth
day 0
Probing depth
Time Frame: day 0
The distance from the gingival margin to bottom of the pocket with using 0.5 mm diameter periodontal probe at mesiobuccal, midbuccal, distobuccal, distolingual, midlingual and mesiolingual sites of each tooth
day 0
Clinical attachment level
Time Frame: day 0
The distance between the cemento-enamel junction and bottom of the pocket
day 0
Community Periodontal Index of Treatment Needs score
Time Frame: day 0
These scores are used to represent healthy periodontium, bleeding after probing, dental calculus detected by probing, 4-5 mm deep pockets and deep pockets ≥ 6 mm, respectively.
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gülin Tulu Katı, PhD, Periodontist in Private Practice., Istanbul, Turkey. (E-mail: gulintulu@gmail.com)
  • Study Chair: Ülkü Noyan, Prof. Dr., Periodontist in Private Practice., Istanbul, Turkey. (E-mail: noyanulku@yahoo.com)
  • Study Chair: Bahar Kuru, Prof. Dr., Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey. (E-mail: baharkuru@gmail.com)
  • Study Director: Leyla Kuru, Prof. Dr., Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (E-mail: lkuru@marmara.edu.tr)
  • Study Chair: Ömer Birkan Ağralı, PhD, Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (omer.agrali@marmara.edu.tr)
  • Study Chair: Hatice Selin Yıldırım, PhD, Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (Email: yildirimselin@hotmail.com)

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MIHS-25

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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