Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-02 @ 6:30 AM
Study NCT ID:
NCT05043935
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2021-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Aggressive Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010520', 'term': 'Aggressive Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2021-09-05', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evaluation and measurements of the defect in millimeters', 'timeFrame': '9 months', 'description': 'Changes in clinical measurements in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF'}, {'measure': 'Radiographic evaluation and measurements of the defect in millimeters', 'timeFrame': '9 months', 'description': 'Changes in bone formation in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['L-PRF', 'Photodynamic Therapy', 'Aggressive Periodontitis']}, 'descriptionModule': {'briefSummary': 'Antimicrobial photodynamic therapy (aPDT) is associated with photosensitizing agents which promote the generation of free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Leukocyte and platelet-rich fibrin (L-PRF) has been used extensively in the treatment of intrabony defects and achieved excellent results. It acts as an immune regulation node with inflammation control abilities, including a slow continuous release of growth factors which stimulates periodontal regeneration. The aim of this study is to evaluate the adjunctive effects of aPDT with and without L-PRF in aggressive periodontitis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy\n* non- smoker,\n* not received any periodontal treatment within the last 6 months,\n* no antibiotics, anti- inflammatory drugs or any other medication taken within the last 6 months\n\nExclusion Criteria:\n\n* any systemic disease that might influence the prognosis of periodontal disease and outcome of the treatment,\n* any medical condition that required antibiotic prophylaxis before the treatment,\n* smoking,\n* pregnancy and lactation,\n* ingestion of antibiotics, anti-inflammatory drugs or any other medication during the study period,\n* any physical limitations or restrictions that might preclude normal oral hygiene procedures.'}, 'identificationModule': {'nctId': 'NCT05043935', 'briefTitle': 'The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Aggressive Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis Patients: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'waiting'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-PRF with antimicrobial photodynamic therapy', 'description': 'Application of L-PRF with antimicrobial photodynamic therapy in the defect', 'interventionNames': ['Procedure: L-PRF with antimicrobial photodynamic therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'antimicrobial photodynamic therapy', 'description': 'Application antimicrobial photodynamic therapy in the defect', 'interventionNames': ['Procedure: antimicrobial photodynamic therapy without L-PRF']}], 'interventions': [{'name': 'L-PRF with antimicrobial photodynamic therapy', 'type': 'PROCEDURE', 'description': 'Application of L-PRF with antimicrobial photodynamic therapy in the defect', 'armGroupLabels': ['L-PRF with antimicrobial photodynamic therapy']}, {'name': 'antimicrobial photodynamic therapy without L-PRF', 'type': 'PROCEDURE', 'description': 'application of antimicrobial photodynamic therapy without L-PRF in the defect', 'armGroupLabels': ['antimicrobial photodynamic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33511', 'city': 'Kafr ash Shaykh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Dalia R Issa, PhD', 'role': 'CONTACT', 'email': 'dalia_rasheed@hotmail.com', 'phone': '01007753636', 'phoneExt': '002'}], 'facility': 'Faculty of Dentistry, Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Dalia R Issa, PhD', 'role': 'CONTACT', 'email': 'dalia_rasheed@hotmail.com', 'phone': '01007753636', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Dalia R Issa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kafrelsheikh University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Dalia Rasheed Issa', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}