Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT07102758
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
L-PRF vs Connective Tissue With Customized Healing Abutment in Immediate Implant Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported pain experience', 'timeFrame': 'first 7 days after surgery', 'description': 'Pain experience after surgery is daily measured by the patients using a visual analogue scale (VAS) in the first postoperative 7 days, with Day 0 being the day of the surgery. Before going to sleep, patients will be asked to mark the VAS that best represented the average pain they had experienced during the day.'}, {'measure': 'Pink aesthetic score', 'timeFrame': 'before surgery, 3 months and 6 months after surgery', 'description': 'Parameters are : 0,1 and 2.\n\nMesial papilla : 0 ( Missing ) , 1 ( Incomplete ) and 2 ( Complete ).\n\nDistal Papilla : 0 ( Missing ) , 1 ( Incomplete ) and 2 ( Complete ).\n\nTissue contour : 0 ( Unnatural) , 1 ( virtually natural ) and 2 ( natural).\n\nGingival level : 0 ( \\>2mm) , 1 ( 1-2mm ) and 2 ( 1 mm).\n\nAlveolar process : 0 ( clearly resorbed ) , 1 ( slightly resorbed ) and 2 ( no difference).\n\nColoring : 0 ( clear difference ) , 1 ( slight difference ) and 2 ( no difference).\n\nTexture : 0 ( clear difference ) , 1 ( slight difference ) and 2 ( no difference).'}, {'measure': 'crestal bone loss', 'timeFrame': 'preoperative and 6 months post operative', 'description': 'distance from implant shoulder to marginal bone'}], 'secondaryOutcomes': [{'measure': 'Gingival thickness', 'timeFrame': 'pre opearative, 3 and 6 months post operative', 'description': '1 mm apical to gingival margin in mid buccal'}, {'measure': 'probing pocket depth', 'timeFrame': 'preoperative , 3 and 6 months post operative', 'description': 'mid buccal , mesio buccal , disto buccal and mid palatal'}, {'measure': 'keratinized tissue width', 'timeFrame': 'preoperative , 3 and 6 months post operative', 'description': 'in mid buccal, from gingival margin to mucogingival junction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['L-prf', 'connective tissue', 'customized healing abutment', 'implant'], 'conditions': ['Recession, Gingival', 'Bone Loss in Jaw']}, 'descriptionModule': {'briefSummary': 'comparison between L-prf and connective tissue with dental implant', 'detailedDescription': 'comparison between L-PRF and Connective tissue with customized healing abutment regaring soft and hard tissue outcomes with immediate dental implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intact labial/buccal bone plate\n* The presence of non-restorable single-rooted maxillary centrals, canines or premolars.\n* Sufficient bone volume.\n* Good oral hygiene.\n* Nonsmokers.\n* Sufficient bone width (≥ 1 mm) in the buccal plate of the remaining bone to place an implant confirmed by cone beam computer tomography (CBCT).\n\nExclusion Criteria:\n\n* Insufficient bone volume.\n* Active infection.\n* Patients on chemotherapy or radiotherapy.\n* Patients who have systemic disorders {uncontrolled diabetes mellitus, autoimmune disease, …etc},\n* Pregnant patients,\n* Patients with bone diseases\n* Presence of periapical pathology.'}, 'identificationModule': {'nctId': 'NCT07102758', 'briefTitle': 'L-PRF vs Connective Tissue With Customized Healing Abutment in Immediate Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Evaluation of Soft and Hard Tissue Augmentation by Connective Tissue Graft or Leukocyte-Platelet Rich Fibrin in Immediate Implant Placement With Customized Healing Abutment: A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'KFSIRB200-436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Connective tissue with dental implant and customized healing abutment', 'description': 'Connective tissue with dental implant and customized healing abutment', 'interventionNames': ['Procedure: Connective tissue with dental implant and customized healing abutment']}, {'type': 'EXPERIMENTAL', 'label': 'L-PRF with dental implant and customized healing abutment', 'description': 'L-PRF with dental implant and customized healing abutment', 'interventionNames': ['Procedure: L-PRF with dental implant and customized healing abutment']}], 'interventions': [{'name': 'L-PRF with dental implant and customized healing abutment', 'type': 'PROCEDURE', 'description': 'L-PRF with dental implant and customized healing abutment', 'armGroupLabels': ['L-PRF with dental implant and customized healing abutment']}, {'name': 'Connective tissue with dental implant and customized healing abutment', 'type': 'PROCEDURE', 'description': 'Connective tissue with dental implant and customized healing abutment', 'armGroupLabels': ['Connective tissue with dental implant and customized healing abutment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Enas Ahmed Elgendy, Dean of Faculty of Dentistry', 'role': 'CONTACT', 'email': 'enas_ahmed@den.kfs.edu', 'phone': '0201003508797'}, {'name': 'Enas Ahmed Elgendy, Dean of Faculty of Dentistry', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Ahmed Atef Salem, General doctor', 'role': 'CONTACT', 'email': 'dent.ahmedatef@gmail.com', 'phone': '0201007737797'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General dentist', 'investigatorFullName': 'Ahmed Atef Salem', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}