Clinical trial NCT02826720: Is There a Relationship Between Hyperlipidemia and Periodontitis?
Official title: Is There a Relationship Between Hyperlipidemia and Periodontitis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia, Periodontal Disease
Keywords: HDL cholesterol
Hyperlipidemia
LDL cholesterol
Periodontal disease
Triglyceride
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 160
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Triglyceride (TG)
timeFrame: day 0
measure: Total cholesterol (TC)
timeFrame: day 0
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: day 0
Secondary outcomes:
measure: Plaque index
timeFrame: day 0
measure: Gingival index
timeFrame: day 0
measure: Bleeding on probing
timeFrame: day 0
measure: Probing depth
timeFrame: day 0
measure: Clinical attachment level
timeFrame: day 0
measure: Community Periodontal Index of Treatment Needs score
timeFrame: day 0
Other outcomes:
Locations:
Study officials:
affiliation: Periodontist in Private Practice., Istanbul, Turkey. (E-mail: gulintulu@gmail.com)
name: Gülin Tulu Katı, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Periodontist in Private Practice., Istanbul, Turkey. (E-mail: noyanulku@yahoo.com)
name: Ülkü Noyan, Prof. Dr.
role: STUDY_CHAIR
affiliation: Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey. (E-mail: baharkuru@gmail.com)
name: Bahar Kuru, Prof. Dr.
role: STUDY_CHAIR
affiliation: Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (E-mail: lkuru@marmara.edu.tr)
name: Leyla Kuru, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (omer.agrali@marmara.edu.tr)
name: Ömer Birkan Ağralı, PhD
role: STUDY_CHAIR
affiliation: Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (Email: yildirimselin@hotmail.com)
name: Hatice Selin Yıldırım, PhD
role: STUDY_CHAIR
References: