Anti-HLA Antibodies After Bone Regeneration Surgery (Anti-HLA Bone)

Assessment of Anti-HLA Antibody Development After Bone Regeneration Procedures and Analysis of Healing Processes

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.

Twenty 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.

Blood 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.

The study aims to determine whether bone graft origin and photobiomodulation therapy influence anti-HLA antibody development and the healing of regenerated bone tissue.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss; Maxillary Sinus Bone Loss
• Intervention / Treatment: Procedure: Xenogeneic Bone Graft; Procedure: Low-Level Laser Therapy; Procedure: Allogeneic Bone Graft

Detailed Description

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.

The 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.

The 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.

The 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.

Before 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.

During 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.

Follow-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.

During 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.

The 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Wroclaw, Poland
    • MCIW - Wroclaw Medical Innovation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18 years or older
• Patients requiring bone augmentation procedures prior to dental implant placement
• Insufficient alveolar bone volume requiring regenerative treatment
• Good general health condition
• Ability and willingness to provide written informed consent

Exclusion Criteria:

• Systemic diseases affecting bone healing

  • Active oral infections or inflammatory conditions at the surgical site
  • Use of medications affecting bone metabolism (e.g., bisphosphonates)
  • Pregnancy or breastfeeding
  • Heavy smoking
  • Previous bone grafting procedures in the planned surgical site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xenogeneic Bone Graft; Patients undergoing bone regeneration procedures received a xenogeneic bone graft material prior to dental implant placement.	Procedure: Xenogeneic Bone Graft; Xenogeneic bone graft material used for bone regeneration procedures prior to dental implant placement during sinus lift surgery.; Other Names: Xenograft
Experimental: Xenogeneic Bone Graft With Photobiomodulation; Patients received a xenogeneic bone graft material during bone regeneration procedures followed by adjunctive postoperative photobiomodulation therapy using low-level laser therapy (LLLT).	Procedure: Xenogeneic Bone Graft; Xenogeneic bone graft material used for bone regeneration procedures prior to dental implant placement during sinus lift surgery.; Other Names: Xenograft; Procedure: Low-Level Laser Therapy; 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.; Other Names: Photobiomodulation LLLT
Experimental: Allogeneic Bone Graft; Patients undergoing bone regeneration procedures received an allogeneic bone graft material prior to dental implant placement.	Procedure: Allogeneic Bone Graft; Allogeneic bone graft material obtained from a human tissue bank and used for bone augmentation procedures prior to dental implant placement.; Other Names: Allograft
Experimental: Allogeneic Bone Graft With Photobiomodulation; Patients received an allogeneic bone graft material during bone regeneration procedures followed by adjunctive postoperative photobiomodulation therapy using low-level laser therapy (LLLT).	Procedure: Low-Level Laser Therapy; 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.; Other Names: Photobiomodulation LLLT; Procedure: Allogeneic Bone Graft; Allogeneic bone graft material obtained from a human tissue bank and used for bone augmentation procedures prior to dental implant placement.; Other Names: Allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anti-HLA Antibody Levels Measured by Luminex Single-Antigen Bead Assay	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.	Baseline and 6 months after bone augmentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic bone regeneration in vertical bone height	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)	6 months after bone augmentation
Histomorphometric Evaluation of Regenerated Bone from Core Biopsies	Histomorphometric analysis of regenerated bone from core biopsies Histomorphometric evaluation of bone core biopsies collected during implant placement to determine: percentage of newly formed bone percentage of connective tissue percentage of residual graft material	6 months after augmentation during implant placement
Bone Healing Parameters in Photobiomodulation vs Control Groups Assessed by CBCT and Histomorphometry	Bone regeneration parameters in photobiomodulation vs control groups assessed by CBCT and histomorphometry Comparison of bone regeneration parameters between groups receiving adjunctive low-level laser therapy (LLLT) and control groups using: CBCT radiographic measurements histomorphometric analysis of bone biopsies	6 months after bone augmentation

Collaborators and Investigators

• Sponsor: Medical Innovation Center Wroclaw
• Collaborators: Wrocław Medical University
• Investigators: Principal Investigator: Paweł Kubasiewicz-Ross, dr hab., Department of Dental Surgery, Faculty of Dentistry, Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): December 29, 2024
• Study Completion (Actual): December 29, 2024

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Photobiomodulation; Bone Regeneration; Sinus Lift; Anti-HLA Antibodies; Allogeneic Bone Graft; Xenogeneic Bone Graft; Dental Implant Therapy
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss; Therapeutics; Surgical Procedures, Operative; Transplantation; Laser Therapy; Phototherapy; Low-Level Light Therapy; Transplantation, Heterologous; Transplantation, Homologous
• Other Study ID Numbers: 2024.Anty.HLA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy considerations and institutional data protection policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No