Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT03923218
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-19', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-04-19', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum D3 Vitamin levels', 'timeFrame': 'Baseline', 'description': 'The plasma levels of vitamin D3 were greater in the CP-2 group than in the CP-1 group. But, no statistically significant difference was determined between the CP groups (P\\>0.05)'}, {'measure': 'Gingival Crevicular fluid(GCF) LL-37 levels', 'timeFrame': 'Baseline', 'description': 'The concentration of LL-37 in GCF was significantly higher in both of the CP groups than in the CTRL group (p\\<0.001). Although GCF LL-37 concentration levels were greater in the CP-1 group than in the CP-2 group, the difference did not reach the statistical significance between the CP groups (p\\>0.05).'}], 'secondaryOutcomes': [{'measure': 'Plaque index (PI)', 'timeFrame': 'Baseline', 'description': 'The full-mouth and sample sites PI recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p\\<0.001).\n\nwere measured on six sites per tooth from the full-mouth teeth'}, {'measure': 'GCF volume', 'timeFrame': 'Baseline', 'description': 'The GCF volume was notably higher in both CP groups than in CTRL group (p\\<0.001).'}, {'measure': 'gingival index (GI)', 'timeFrame': 'Baseline', 'description': 'The full-mouth and sample sites GI recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p\\<0.001).'}, {'measure': 'Probing depth (PD)', 'timeFrame': 'Baseline', 'description': 'The full-mouth and sample sites PD recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p\\<0.001).'}, {'measure': 'Clinical attachment level (CAL)', 'timeFrame': 'Baseline', 'description': 'The full-mouth and sample sites CAL recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p\\<0.001).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival crevicular fluid', 'Vitamin D', 'LL-37', 'Serum', 'periodontitis'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The aims of our study were 1) to evaluate levels of gingival crevicular fluid( GCF) human cathelicidin peptide LL-37 and serum vitamin D3 in smoker and non-smoker patients with chronic periodontitis(CP) 2) to determine whether any correlation between GCF LL-37 and vitamin D3 serum levels exist and 3) to asses the correlation between clinical parameters and biochemical markers', 'detailedDescription': "Background: Cathelicidin LL-37, an antimicrobial peptide, is part of the host innate immune response in the oral cavity. The aims of this study are to evaluate; gingival crevicular fluid (GCF) levels of LL-37, serum vitamin D3 levels and periodontal clinical recordings in smoker and nonsmoker patients with chronic periodontitis (CP).\n\nMethods:\n\nThis study consisted a total of 60 volunteers including 20 smoker patients with CP (CP-1 group), 20 non-smoker patients with CP (CP-2 group) and 20 periodontally healthy subjects (CTRL group). Prior to participation, the design and purpose of the research were explained to each subjects, and written informed consent form was obtained from 60 individuals before the study.\n\nThe periodontal status of the patients were determined by measuring the probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) All clinical parameters were measured on six sites per tooth from the full-mouth teeth (mesiobuccal, distobuccal,midbuccal, mesiolingual, distolingual and midlingual) using a William's periodontal probe calibrated in millimeters by the same examiner. All samples were obtained on the day following clinical examinations of the individuals. The deepest six pockets site per individual were chosen for collection of GCF across both of the periodontitis groups. Six pocket locations showing a lack of clinical inflammation were also tested to guarantee collection of a sufficient volume of GCF across the CTRL groups.\n\nGCF levels of LL-37 were measured by ELISA and serum levels of vitamin D3 were analysed by High-performance liquid chromatography (HPLC). Statistical analysis were performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The volunteers participitating in the study were choosen from among individuals scheduled to undergo either dental treatment or dental check at the Deparment of Perioodontology, Faculty of Dentistry, Gazi University, Ankara, Turkey.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for chronic periodontitis groups:\n\n* Clinical attachment loss ≥ 5mm\n* Probing depth ≥5mm\n* Bone loss affecting \\>30% of the existing teeth on clinical and radiographic examination\n* gingival index (GI) score\\> 1\n\nInclusion criteria for control group:\n\n* full-mouth PD was≤ 3mm,\n* Gingival index \\<1\n* there was no indication of Attachment Loss or no radiographic evidence of alveolar bone loss in control group.\n* Non-smokers.\n\nSmoking criteria for groups:\n\n* patients smoked more than 10 cigarettes in a day\n* smoking for 3 or more years,\n\nExclusion Criteria:\n\n* systemic condition (diabetes, cardiovascular disease, immunologic disorders, hepatitis, e.g.)\n* pregnancy, lactation or menopause term,\n* antibiotic treatment or non-steroidal anti-inflammatory medications within the last 3 months before the study,\n* non-surgical periodontal treatment during the last 6 months before the study,\n* treatment with Vitamin D supplementation before the study'}, 'identificationModule': {'nctId': 'NCT03923218', 'briefTitle': 'Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Evaluation of Gingival Crevicular Fluid Levels of LL-37 and Serum Vitamin D3 Levels in Smoker and Non-Smoker Patients With Chronic Periodontitis', 'orgStudyIdInfo': {'id': '03/2011-27'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smoker patients with chronic periodontitis', 'description': 'Smoker patients with chronic periodontitis', 'interventionNames': ['Other: LL-37 levels in Gingival crevicular fluid', 'Other: Serum Vitamin D3 levels', 'Other: Clinical parameters']}, {'label': 'non-smoker patients with chronic periodontitis', 'description': 'non-smoker patients with chronic periodontitis', 'interventionNames': ['Other: LL-37 levels in Gingival crevicular fluid', 'Other: Serum Vitamin D3 levels', 'Other: Clinical parameters']}, {'label': 'periodontally healthy patients', 'description': 'periodontally healthy patients', 'interventionNames': ['Other: LL-37 levels in Gingival crevicular fluid', 'Other: Serum Vitamin D3 levels', 'Other: Clinical parameters']}], 'interventions': [{'name': 'LL-37 levels in Gingival crevicular fluid', 'type': 'OTHER', 'description': 'Collected gingival crevicular fluid', 'armGroupLabels': ['Smoker patients with chronic periodontitis', 'non-smoker patients with chronic periodontitis', 'periodontally healthy patients']}, {'name': 'Serum Vitamin D3 levels', 'type': 'OTHER', 'description': 'Collected serum', 'armGroupLabels': ['Smoker patients with chronic periodontitis', 'non-smoker patients with chronic periodontitis', 'periodontally healthy patients']}, {'name': 'Clinical parameters', 'type': 'OTHER', 'description': 'Recorded plague index, gingival index, probing depth, clinical attachment level', 'armGroupLabels': ['Smoker patients with chronic periodontitis', 'non-smoker patients with chronic periodontitis', 'periodontally healthy patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Şeyma BOZKURT DOĞAN, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'university'}, {'name': 'Elifcan Kıvrak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gülay Tüter', 'investigatorAffiliation': 'Gazi University'}}}}