- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826720
Is There a Relationship Between Hyperlipidemia and Periodontitis?
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
No intervention was applied
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Investigators
- 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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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