Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-04-18 @ 6:47 AM
Study NCT ID:
NCT02826720
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2016-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is There a Relationship Between Hyperlipidemia and Periodontitis?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-05', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-07-05', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglyceride (TG)', 'timeFrame': 'day 0', 'description': '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'}, {'measure': 'Total cholesterol (TC)', 'timeFrame': 'day 0', 'description': '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'}, {'measure': 'Low density lipoprotein cholesterol (LDL-C)', 'timeFrame': 'day 0', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Plaque index', 'timeFrame': 'day 0', 'description': 'The measurement of the state of oral hygiene based on recording dental plaque accumulation'}, {'measure': 'Gingival index', 'timeFrame': 'day 0', 'description': 'An assessment level of gingival health and inflammation'}, {'measure': 'Bleeding on probing', 'timeFrame': 'day 0', 'description': 'A sign of gingival inflammation were assessed on the buccal, lingual, mesial and distal sites of each tooth'}, {'measure': 'Probing depth', 'timeFrame': 'day 0', 'description': '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'}, {'measure': 'Clinical attachment level', 'timeFrame': 'day 0', 'description': 'The distance between the cemento-enamel junction and bottom of the pocket'}, {'measure': 'Community Periodontal Index of Treatment Needs score', 'timeFrame': 'day 0', 'description': '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.'}]}, 'conditionsModule': {'keywords': ['HDL cholesterol', 'Hyperlipidemia', 'LDL cholesterol', 'Periodontal disease', 'Triglyceride'], 'conditions': ['Hyperlipidemia, Periodontal Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects having no periodontal treatment within previous 6 months,\n* number of natural teeth ≥ 10,\n* no history of cancer and systemic disease that affects lipid levels or periodontium,\n* no history of medical treatment for hyperlipidemia, BMI\\< 30 kg/m2,\n* no pregnancy,\n* no history of systemic antibiotic treatment within previous 3 months,\n* no smoking.\n\nExclusion Criteria:\n\n* patients with history of systemic disease that affects lipid metabolism or periodontal disease\n* history of medical treatment for hyperlipidemia\n* pregnancy, lactation or hormone replacement therapy at the time of study\n* use of any other drug known to affect lipid metabolism or periodontal disease\n* systemic infection or any history of systemic antibiotic treatment in previous 3 months\n* smokers as well as ex-smokers'}, 'identificationModule': {'nctId': 'NCT02826720', 'briefTitle': 'Is There a Relationship Between Hyperlipidemia and Periodontitis?', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Is There a Relationship Between Hyperlipidemia and Periodontitis?', 'orgStudyIdInfo': {'id': 'MIHS-25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HP+', 'description': "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.", 'interventionNames': ['Other: No intervention was applied']}, {'label': 'HP-', 'description': "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.", 'interventionNames': ['Other: No intervention was applied']}, {'label': 'NP+', 'description': "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.", 'interventionNames': ['Other: No intervention was applied']}, {'label': 'NP-', 'description': "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.", 'interventionNames': ['Other: No intervention was applied']}], 'interventions': [{'name': 'No intervention was applied', 'type': 'OTHER', 'description': 'No intervention was applied', 'armGroupLabels': ['HP+', 'HP-', 'NP+', 'NP-']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gülin Tulu Katı, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Periodontist in Private Practice., Istanbul, Turkey. (E-mail: gulintulu@gmail.com)'}, {'name': 'Ülkü Noyan, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Periodontist in Private Practice., Istanbul, Turkey. (E-mail: noyanulku@yahoo.com)'}, {'name': 'Bahar Kuru, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey. (E-mail: baharkuru@gmail.com)'}, {'name': 'Leyla Kuru, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (E-mail: lkuru@marmara.edu.tr)'}, {'name': 'Ömer Birkan Ağralı, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (omer.agrali@marmara.edu.tr)'}, {'name': 'Hatice Selin Yıldırım, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (Email: yildirimselin@hotmail.com)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}