Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-31 @ 12:41 PM
Study NCT ID:
NCT03558906
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2018-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TNF-α/HIF-1α/VEGF Pathway in Periodontal Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Gingival crevicular fluid, saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-14', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival crevicular fluid HIF-1α levels', 'timeFrame': 'A day after clinical periodontal examination', 'description': 'pg'}], 'secondaryOutcomes': [{'measure': 'Salivary HIF-1α levels', 'timeFrame': 'A day after clinical periodontal examination', 'description': 'pg/ml'}, {'measure': 'Gingival crevicular fluid VEGF levels', 'timeFrame': 'A day after clinical periodontal examination', 'description': 'ng'}, {'measure': 'Salivary VEGF levels', 'timeFrame': 'A day after clinical periodontal examination', 'description': 'ng/l'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontal disease', 'Hypoxia', 'Cytokines', 'Gingival crevicular fluid', 'Saliva'], 'conditions': ['Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '30536725', 'type': 'DERIVED', 'citation': 'Afacan B, Ozturk VO, Pasali C, Bozkurt E, Kose T, Emingil G. Gingival crevicular fluid and salivary HIF-1alpha, VEGF, and TNF-alpha levels in periodontal health and disease. J Periodontol. 2019 Jul;90(7):788-797. doi: 10.1002/JPER.18-0412. Epub 2018 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate gingival crevicular fluid (GCF) and salivary hypoxia inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor (VEGF) and tumor necrosis factor-alpha (TNF-α) levels in different periodontal diseases. A total of 87 individuals, 20 patients with generalized aggressive periodontitis, 20 with chronic periodontitis, 26 with gingivitis and 21 periodontally healthy individuals were included. Whole-mouth and site-specific clinical periodontal parameters including probing depth, clinical attachment level, bleeding on probing, gingival index and plaque index were recorded. GCF and salivary HIF-1α, VEGF and TNF-α levels were measured by enzyme-linked immunosorbent assay. Statistical analysis was performed by using non-parametric tests.', 'detailedDescription': "Study Population and Clinical Examination\n\nEighty-seven participants were recruited for the study. Exclusion criteria were as follows: 1) systemic diseases that could affect the periodontium; 2) smoking; 3) current pregnancy or lactation; 4) nonsurgical/surgical periodontal treatment received for the past year; and 5) use of anti-inflammatory and antibiotic drugs within the past 6 months.\n\nThe full-mouth clinical periodontal examination included measurement of probing depth (PD), clinical attachment level (CAL), presence of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) at 6 sites per tooth. Presence and extent of alveolar bone loss were assessed radiographically. Based on clinical and radiographic diagnostic criteria proposed by 1999 International Workshop for a Classification of Periodontal Diseases and Conditions, the participants were categorized into four groups.\n\nI. Generalized aggressive periodontitis (GAgP) group (n=20). These individuals had minimum PD ≥6 mm and CAL ≥5 mm on eight or more teeth; at least three of these were other than central incisors or first molars. Radiographic alveolar bone loss was ≥30% of root length affecting at least three permanent teeth other than first molars and incisors. The severe destruction pattern was not commensurate with amount of plaque accumulation or other local risk factors for a given age.\n\nII. Chronic periodontitis (CP) group (n=20). These individuals had at least four non-adjacent teeth with sites with PD ≥6 mm and CAL ≥5 mm. They had also ≥50% alveolar bone loss in at least two quadrants that was commensurate with amount of plaque accumulation. BOP was \\>50% in the whole mouth.\n\nIII. Gingivitis group (n=26). These individuals had varying degrees of gingival inflammation. They exhibited no sites with CAL \\>2 mm and no detectable alveolar bone loss in the radiography. BOP was \\>50% in the whole mouth.\n\nIV. Healthy group (n=21). These periodontally healthy volunteers exhibited no sites with PD \\>3 mm and CAL \\>2 mm as well as no radiographic evidence of alveolar bone loss. BOP was \\<15% in the whole mouth.\n\nSaliva sampling\n\nWhole unstimulated saliva samples were collected. Each participant was asked first to rinse the mouth completely with tap water for 2 minutes, wait for 10 minutes, and then expectorate into sterile polypropylene tube for 5 minutes.\n\nGingival crevicular fluid (GCF) sampling\n\nStandardized filter paper strips were used for GCF sampling. Two GCF samples were taken from the buccal aspects of two non-adjacent interproximal sites of each individual. In patients with periodontitis, GCF were sampled from two sites exhibiting PD ≥6 mm and CAL ≥5 mm. GCF samples of gingivitis patients were obtained from the sites that exhibit BOP but no clinical attachment loss. In the healthy group, GCF samples were collected the sites exhibiting PD \\<3 mm without BOP and clinical attachment loss.\n\nMeasurement of hypoxia inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor (VEGF) and tumor necrosis factor-alpha (TNF-α) Levels in GCF and Saliva Samples\n\nHIF-1α, VEGF and TNF-α levels in GCF and saliva samples were measured by the enzyme-linked immunosorbent assay (ELISA) using commercial kits according to the manufacturer's guidelines.\n\nStatistical Analysis\n\nAll data analyses were performed using a statistical software package. Comparisons of clinical and biochemical parameters between the study groups were performed using the Kruskal-Wallis test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '27 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive individuals were recruited from the Department of Periodontology, School of Dentistry, Adnan Menderes University, Aydın.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Systemically healthy individuals\n2. Non-smoker individuals\n\nExclusion Criteria:\n\n1. Current pregnancy or lactation\n2. Nonsurgical/surgical periodontal treatment received for the past year\n3. Use of anti-inflammatory and antibiotic drugs within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT03558906', 'briefTitle': 'TNF-α/HIF-1α/VEGF Pathway in Periodontal Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Gingival Crevicular Fluid and Salivary HIF-1α, VEGF and TNF-α Levels in Different Periodontal Diseases', 'orgStudyIdInfo': {'id': 'bafacan357'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aggressive Periodontitis', 'description': 'These individuals had minimum PD ≥6 mm and CAL ≥5 mm on eight or more teeth; at least three of these were other than central incisors or first molars. Radiographic alveolar bone loss was ≥30% of root length affecting at least three permanent teeth other than first molars and incisors. The severe destruction pattern was not commensurate with amount of plaque accumulation.'}, {'label': 'Chronic periodontitis', 'description': 'These individuals had at least four non-adjacent teeth with sites with PD ≥6 mm and CAL ≥5 mm. They had also ≥50% alveolar bone loss in at least two quadrants that was commensurate with amount of plaque accumulation. BOP was \\>50% in the whole mouth.'}, {'label': 'Gingivitis', 'description': 'Gingivitis patients exhibited no sites with CAL \\>2 mm and no detectable alveolar bone loss in the radiography. BOP was \\>50% in the whole mouth.'}, {'label': 'Healthy', 'description': 'Periodontally healthy volunteers exhibited no sites with PD \\>3 mm and CAL \\>2 mm as well as no radiographic evidence of alveolar bone loss. BOP was \\<15% in the whole mouth.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celal Bayar University', 'class': 'OTHER'}, {'name': 'Ege University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Beral Afacan', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}