Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-01-31 @ 1:49 AM
Study NCT ID:
NCT04383561
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between LRG and Periodontal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D000210', 'term': 'Acute-Phase Reaction'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the levels of biochemical parameters', 'timeFrame': 'Baseline and 6 weeks after treatment', 'description': 'The levels LRG, IL-6 and TNF-α were determined to define the diagnostic and prognostic potential as a biomarker in periodontitis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontitis', 'gingival crevicular fluid', 'serum'], 'conditions': ['Periodontitis', 'Acute-Phase Response', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate gingival crevicular fluid (GCF) and serum levels of LRG, interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with periodontitis before and after non-surgical periodontal treatment.', 'detailedDescription': 'Twenty-five stage 3 periodontitis and twenty-five periodontally healthy individuals were enrolled in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and serum samples were obtained at baseline and at 6 weeks after treatment. LRG, IL-6 and TNF-α were determined by ELISA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '26 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 25-50 years of age\n2. having at least 20 natural teeth, excluding third molars\n3. having no systemic disease\n4. non-smokers\n5. criteria for healthy control group: BOP \\< 10% and PD ≤ 3 mm without clinical attachment loss or radiographic sign of alveolar bone destruction\n6. criteria for stage 3 periodontitis group: interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss extending to the mid-third of the root or beyond.\n\nExclusion Criteria:\n\n1. having any systemic diseases,\n2. smoking\n3. current pregnancy or lactation\n4. a history of periodontal treatment in the past 6 months\n5. using antibiotic, anti-inflammatory drugs or any other drugs within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT04383561', 'briefTitle': 'Relationship Between LRG and Periodontal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Leucin-rich alpha2 Glycoprotein (LRG): A Novel Acute Phase Protein Related With Stage 3 Periodontitis', 'orgStudyIdInfo': {'id': 'KAEK-92'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stage 3 periodontitis', 'description': 'GCF and serum samples were collected before and after treatment from periodontitis patients.', 'interventionNames': ['Other: Non-surgical periodontal treatment', 'Other: Oral hygiene instructions']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Periodontally healthy controls', 'description': 'GCF and serum samples were collected from periodontally healthy controls at baseline for once.', 'interventionNames': ['Other: Oral hygiene instructions']}], 'interventions': [{'name': 'Non-surgical periodontal treatment', 'type': 'OTHER', 'description': 'Scaling and root planing (SRP), in four clinical visits', 'armGroupLabels': ['stage 3 periodontitis']}, {'name': 'Oral hygiene instructions', 'type': 'OTHER', 'description': 'Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.', 'armGroupLabels': ['Periodontally healthy controls', 'stage 3 periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28100', 'city': 'Giresun', 'country': 'Turkey (Türkiye)', 'facility': 'Giresun University', 'geoPoint': {'lat': 40.91698, 'lon': 38.38741}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Giresun University', 'class': 'OTHER'}, {'name': 'Bulent Ecevit University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Prof.', 'investigatorFullName': 'Zeynep Pinar KELES YUCEL', 'investigatorAffiliation': 'Giresun University'}}}}