Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06789458
Status:
RECRUITING
Last Update Posted:
2025-01-23
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in level of GCF lipoxin A4', 'timeFrame': 'preoperative, one day, one month and 3 months postoperative'}], 'secondaryOutcomes': [{'measure': 'Change in level of GCF Protectin', 'timeFrame': 'preoperative, one day, one month and 3 months postoperative'}, {'measure': 'Probing pocket depth (PPD)', 'timeFrame': 'preoperative, and 3 months postoperative'}, {'measure': 'Bleeding On Probing (BOP)', 'timeFrame': 'preoperative, and 3 months postoperative'}, {'measure': 'Plaque index (PI)', 'timeFrame': 'preoperative, and 3 months postoperative'}, {'measure': 'Clinical Attachment Level (CAL)', 'timeFrame': 'preoperative, and 3 months postoperative'}, {'measure': 'Number of pockets closed', 'timeFrame': 'preoperative, and 3 months postoperative'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lipoxin', 'proresolution mediators'], 'conditions': ['Peridontal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1186/s12903-024-03948-w', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess Pro-Resolution Mediator levels during non-surgical periodontal therapy in individuals with Stage III and IV periodontitis, comparing them to healthy subjects. Periodontitis, a chronic inflammatory condition affecting tooth-supporting tissues, can lead to tooth loss and systemic complications. Understanding the role of pro-resolving lipid mediators in inflammation resolution may offer insights into therapeutic benefits associated with these mediators.', 'detailedDescription': "Periodontitis is a chronic inflammatory disease that affects the tooth-supporting tissues, it produces a slow destruction of the periodontium that may eventually result in tooth loss. Periodontitis is caused by a dysbiosis of the immune system where there is an imbalance between the processes that activate and terminate the inflammatory process.(Van Dyke, 2020) Pro-resolving lipid mediators (PMs) play a key role in actively resolving inflammation, modulating immune responses, and promoting tissue healing. However, the understanding of PMs in periodontitis and their role in the enduring nature of the disease has not been sufficiently studied in a clinical setting. It has been suggested that PM levels vary between periodontitis patients and healthy individual with periodontal therapy potentially restoring the balance between pro- and anti-inflammatory mediators. (Van Dyke, 2017) The study aims to provide insights into inflammation resolution mechanisms in periodontitis and the therapeutic potential of PMs.\n\nThis study aims to Assess Pro-Resolution Mediator Levels During Periodontal Therapy in Patients with Periodontitis Stage III and IV compared to healthy patients.\n\nHypothesis Null Hypothesis: pro-resolution mediators' level before and after non-surgical treatment in stage III and IV periodontitis compared to healthy patients, there will be no difference in level before and after non-surgical treatment between stage III and IV periodontitis compared to healthy patients.\n\nTrial design:\n\nThe current study design is a before and after trial with a single (interventional) population measured before and after treatment compared to a negative control of healthy patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria:\n\n1. Adult patients above 18 years old.\n2. Interdental CAL at site of greatest loss ≥5 mm or extending to middle third of the root.\n3. Interdental CAL at site of greatest loss ≥8 mm or extending to apical third of the root.\n4. Probing depth ≥6 mm.\n5. Vertical bone loss ≥3 mm.\n6. Tooth loss due to periodontitis of ≤4 teeth. (Periodontitis Stage III)\n7. Tooth loss due to periodontitis of ≥5 teeth. (Periodontitis Stage IV)\n8. Furcation involvement Class II or III Moderate ridge defect.\n\n \\-\n\nExclusion Criteria:\n\n* 1\\. Pregnancy or lactation. 2. Smoking more than 20 cigarettes. 3. Immuno-inflammatory conditions of the skin and oral mucosa 4. systemic conditions affecting bone turnover and periodontal health status (e.g. endocrine and connective tissue diseases, bisphosphonate antiresorptive therapy, gastrointestinal diseases related to nutrition and mineral metabolism) 5. Periodontal or orthodontic treatment at least 6 months before the start of the study 6. Use of anti-inflammatory and antimicrobial agents within 3 months before sampling\n\nInclusion criteria for healthy group:\n\n1. Systemically healthy patients.\n2. Patients with an age range between 16 to 80 years.\n3. Patients have a minimum of 20 teeth.\n4. Less than 10% bleeding sites with probing depths ≤3 mm.\n5. absence of erythema, oedema.'}, 'identificationModule': {'nctId': 'NCT06789458', 'briefTitle': 'Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy', 'orgStudyIdInfo': {'id': '20042024PER7_2_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Healthy Control', 'description': 'Systemically healthy patient'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Periodontitis Stage III and IV', 'description': 'Professional mechanical plaque control', 'interventionNames': ['Procedure: Professional mechanical plaque control']}], 'interventions': [{'name': 'Professional mechanical plaque control', 'type': 'PROCEDURE', 'description': 'thisThe first step in therapy is aimed at guiding behavior change by motivating the patient to undertake successful removal of supragingival dental biofilm and risk factor control and may include the following interventions:\n\n* Interventions to improve the effectiveness of oral hygiene \\[motivation, instructions (oral hygiene instructions, OHI)\n* Professional mechanical plaque removal (PMPR), which includes the professional interventions aimed at removing supragingival plaque and calculus, as well as possible plaque-retentive factors that impair oral hygiene practices.\n* Adjustment of faulty restoration and polishing\n* The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.', 'armGroupLabels': ['Periodontitis Stage III and IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Manial', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Faculty of Dentistry-Cairo University'}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Husam Ghazi alharbi', 'role': 'CONTACT', 'email': 'husam.ghazi@dentistry.cu.edu.eg', 'phone': '0223642705'}], 'facility': 'faculty of dentistry Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Husam Ghazi Alharbi, Master Degree', 'role': 'CONTACT', 'email': 'husam.ghazi@dentistry.cu.edu.eg', 'phone': '+201222284055', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Husam Ghazi Dwerj Alharbi', 'investigatorFullName': 'Husam Ghazi Dwerj Alharbi', 'investigatorAffiliation': 'Cairo University'}}}}