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Trial record 5 of 9 for:    Kuru

Is There a Relationship Between Hyperlipidemia and Periodontitis?

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ClinicalTrials.gov Identifier: NCT02826720
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Marmara University

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.


Condition or disease Intervention/treatment
Hyperlipidemia, Periodontal Disease Other: No intervention was applied

Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Is There a Relationship Between Hyperlipidemia and Periodontitis?
Study Start Date : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources

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.
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Plaque index [ Time Frame: day 0 ]
    The measurement of the state of oral hygiene based on recording dental plaque accumulation

  2. Gingival index [ Time Frame: day 0 ]
    An assessment level of gingival health and inflammation

  3. 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

  4. 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

  5. Clinical attachment level [ Time Frame: day 0 ]
    The distance between the cemento-enamel junction and bottom of the pocket

  6. 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.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826720


Sponsors and Collaborators
Marmara University
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)

Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT02826720     History of Changes
Other Study ID Numbers: MIHS-25
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by Marmara University:
HDL cholesterol
Hyperlipidemia
LDL cholesterol
Periodontal disease
Triglyceride

Additional relevant MeSH terms:
Periodontitis
Hyperlipidemias
Hyperlipoproteinemias
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases