Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-05 @ 8:17 PM
Study NCT ID:
NCT07474857
Status:
COMPLETED
Last Update Posted:
2026-03-16
First Post:
2026-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-HLA Antibodies After Bone Regeneration Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014183', 'term': 'Transplantation, Heterologous'}, {'id': 'D014184', 'term': 'Transplantation, Homologous'}, {'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Histological and radiological evaluations were performed by investigators who were not involved in the surgical procedures and were blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants undergoing bone regeneration procedures prior to implant therapy were assigned to receive either xenogeneic or allogeneic bone graft material. Additionally, a subgroup of participants received adjunctive photobiomodulation using low-level laser therapy (LLLT) during the postoperative period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Anti-HLA Antibody Levels Measured by Luminex Single-Antigen Bead Assay', 'timeFrame': 'Baseline and 6 months after bone augmentation', 'description': 'Change in serum anti-HLA antibody levels measured by Luminex single-antigen bead assay Assessment of changes in serum anti-human leukocyte antigen (anti-HLA) antibody levels following bone regeneration procedures using xenogeneic or allogeneic graft materials. Antibody levels will be measured using a Luminex single-antigen bead immunoassay.'}], 'secondaryOutcomes': [{'measure': 'Radiographic bone regeneration in vertical bone height', 'timeFrame': '6 months after bone augmentation', 'description': 'Radiographic bone regeneration assessed by cone-beam computed tomography (CBCT) Evaluation of bone regeneration in the augmented area using CBCT imaging, including vertical bone height gain (in mm)'}, {'measure': 'Histomorphometric Evaluation of Regenerated Bone from Core Biopsies', 'timeFrame': '6 months after augmentation during implant placement', 'description': 'Histomorphometric analysis of regenerated bone from core biopsies\n\nHistomorphometric evaluation of bone core biopsies collected during implant placement to determine:\n\npercentage of newly formed bone percentage of connective tissue percentage of residual graft material'}, {'measure': 'Bone Healing Parameters in Photobiomodulation vs Control Groups Assessed by CBCT and Histomorphometry', 'timeFrame': '6 months after bone augmentation', 'description': 'Bone regeneration parameters in photobiomodulation vs control groups assessed by CBCT and histomorphometry\n\nComparison of bone regeneration parameters between groups receiving adjunctive low-level laser therapy (LLLT) and control groups using:\n\nCBCT radiographic measurements histomorphometric analysis of bone biopsies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sinus Lift', 'Bone Regeneration', 'Anti-HLA Antibodies', 'Allogeneic Bone Graft', 'Xenogeneic Bone Graft', 'Photobiomodulation', 'Dental Implant Therapy'], 'conditions': ['Alveolar Bone Loss', 'Maxillary Sinus Bone Loss']}, 'descriptionModule': {'briefSummary': 'This study evaluates the occurrence of anti-human leukocyte antigen (anti-HLA) antibodies following bone regeneration procedures performed prior to dental implant therapy. Allogeneic bone grafts are widely used in regenerative oral surgery due to their favorable osteoconductive and osteoinductive properties; however, their use may be associated with the development of anti-HLA antibodies, which could potentially influence graft integration and healing.\n\nTwenty generally healthy adult patients requiring bone augmentation procedures before implant therapy will be included in the study. Patients will receive either a xenogeneic or allogeneic bone graft material during the regenerative procedure. Additionally, half of the participants will receive adjunctive low-level laser therapy (LLLT) in the postoperative period.\n\nBlood samples will be collected before surgery and during follow-up to assess anti-HLA antibody levels. Radiological evaluation using cone-beam computed tomography (CBCT) will be performed to assess bone regeneration. After a healing period of approximately 3-6 months, bone samples will be collected during implant placement and analyzed histologically.\n\nThe study aims to determine whether bone graft origin and photobiomodulation therapy influence anti-HLA antibody development and the healing of regenerated bone tissue.', 'detailedDescription': 'Bone regeneration procedures are frequently required before implant-supported prosthetic rehabilitation in patients with insufficient alveolar bone volume. Allogeneic bone graft materials are widely used in oral and maxillofacial surgery because of their favorable osteoconductive properties and biological similarity to human bone. Despite these advantages, concerns have been raised regarding the possible immunological response associated with their use, including the development of anti-human leukocyte antigen (anti-HLA) antibodies.\n\nThe presence of anti-HLA antibodies has been well documented in large organ and tissue transplantation procedures. However, recent reports suggest that even smaller regenerative procedures involving allogeneic bone grafts may lead to the development of these antibodies. Such immunological reactions may potentially influence graft integration, healing dynamics, and the overall regenerative outcome.\n\nThe aim of this clinical study is to evaluate changes in anti-HLA antibody levels following bone regeneration procedures and to analyze their potential association with bone healing processes. In addition, the study investigates whether adjunctive photobiomodulation using low-level laser therapy (LLLT) may influence the regenerative process.\n\nThe study includes twenty generally healthy adult patients who require bone augmentation prior to implant-supported rehabilitation. Patients undergo regenerative procedures involving either xenogeneic or allogeneic bone graft materials. In addition, a subgroup of participants receives postoperative photobiomodulation therapy using a diode laser.\n\nBefore surgery, patients undergo clinical and radiological evaluation, including cone-beam computed tomography (CBCT), to assess the anatomical conditions and plan the surgical procedure. Blood samples are collected prior to surgery to determine baseline levels of anti-HLA antibodies.\n\nDuring the regenerative procedure, bone graft material is placed in the area of the bone defect under local anesthesia using standard surgical techniques. In patients allocated to photobiomodulation therapy, diode laser irradiation is applied in the postoperative period according to the study protocol.\n\nFollow-up evaluation is performed approximately three to six months after the augmentation procedure. At this stage, additional blood samples are collected to assess secondary anti-HLA antibody levels. Radiological examination using CBCT is repeated to evaluate bone regeneration parameters.\n\nDuring implant placement, bone core biopsies are obtained using a trephine drill to allow histological assessment of regenerated bone tissue. Histological analysis includes evaluation of inflammatory cell infiltrates, trabecular bone formation, and bone morphology.\n\nThe results of this study are expected to improve understanding of the immunological response associated with bone grafting procedures and may contribute to the development of more predictable regenerative treatment strategies in implant dentistry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Patients requiring bone augmentation procedures prior to dental implant placement\n* Insufficient alveolar bone volume requiring regenerative treatment\n* Good general health condition\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Systemic diseases affecting bone healing\n\n * Active oral infections or inflammatory conditions at the surgical site\n * Use of medications affecting bone metabolism (e.g., bisphosphonates)\n * Pregnancy or breastfeeding\n * Heavy smoking\n * Previous bone grafting procedures in the planned surgical site'}, 'identificationModule': {'nctId': 'NCT07474857', 'acronym': 'Anti-HLA Bone', 'briefTitle': 'Anti-HLA Antibodies After Bone Regeneration Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical Innovation Center Wroclaw'}, 'officialTitle': 'Assessment of Anti-HLA Antibody Development After Bone Regeneration Procedures and Analysis of Healing Processes', 'orgStudyIdInfo': {'id': '2024.Anty.HLA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xenogeneic Bone Graft', 'description': 'Patients undergoing bone regeneration procedures received a xenogeneic bone graft material prior to dental implant placement.', 'interventionNames': ['Procedure: Xenogeneic Bone Graft']}, {'type': 'EXPERIMENTAL', 'label': 'Xenogeneic Bone Graft With Photobiomodulation', 'description': 'Patients received a xenogeneic bone graft material during bone regeneration procedures followed by adjunctive postoperative photobiomodulation therapy using low-level laser therapy (LLLT).', 'interventionNames': ['Procedure: Xenogeneic Bone Graft', 'Procedure: Low-Level Laser Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Allogeneic Bone Graft', 'description': 'Patients undergoing bone regeneration procedures received an allogeneic bone graft material prior to dental implant placement.', 'interventionNames': ['Procedure: Allogeneic Bone Graft']}, {'type': 'EXPERIMENTAL', 'label': 'Allogeneic Bone Graft With Photobiomodulation', 'description': 'Patients received an allogeneic bone graft material during bone regeneration procedures followed by adjunctive postoperative photobiomodulation therapy using low-level laser therapy (LLLT).', 'interventionNames': ['Procedure: Allogeneic Bone Graft', 'Procedure: Low-Level Laser Therapy']}], 'interventions': [{'name': 'Xenogeneic Bone Graft', 'type': 'PROCEDURE', 'otherNames': ['Xenograft'], 'description': 'Xenogeneic bone graft material used for bone regeneration procedures prior to dental implant placement during sinus lift surgery.', 'armGroupLabels': ['Xenogeneic Bone Graft', 'Xenogeneic Bone Graft With Photobiomodulation']}, {'name': 'Allogeneic Bone Graft', 'type': 'PROCEDURE', 'otherNames': ['Allograft'], 'description': 'Allogeneic bone graft material obtained from a human tissue bank and used for bone augmentation procedures prior to dental implant placement.', 'armGroupLabels': ['Allogeneic Bone Graft', 'Allogeneic Bone Graft With Photobiomodulation']}, {'name': 'Low-Level Laser Therapy', 'type': 'PROCEDURE', 'otherNames': ['Photobiomodulation LLLT'], 'description': 'Postoperative photobiomodulation performed using a diode laser device (Smart M, Lasotronix, Poland). Four irradiation sessions were performed with an energy density of 4 J/cm2 for approximately 20 seconds per session.', 'armGroupLabels': ['Allogeneic Bone Graft With Photobiomodulation', 'Xenogeneic Bone Graft With Photobiomodulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wroclaw', 'country': 'Poland', 'facility': 'MCIW - Wroclaw Medical Innovation Center', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Paweł Kubasiewicz-Ross, dr hab.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dental Surgery, Faculty of Dentistry, Wroclaw Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to privacy considerations and institutional data protection policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Innovation Center Wroclaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wrocław Medical University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Deputy Head of the Specialist Outpatient Clinic, MCIW, Wroclaw Medical University', 'investigatorFullName': 'Jakub Hadzik', 'investigatorAffiliation': 'Medical Innovation Center Wroclaw'}}}}