Anti-HLA Antibodies After Bone Regeneration Surgery

NCT07474857 | Completed

• 1 other identifier: 2024.Anty.HLA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Bone Loss; Maxillary Sinus Bone Loss

Keywords

Sinus Lift; Bone Regeneration; Anti-HLA Antibodies; Allogeneic Bone Graft; Xenogeneic Bone Graft; Photobiomodulation; Dental Implant Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Radiographic bone regeneration in vertical bone height

  6 months after bone augmentation

• Histomorphometric Evaluation of Regenerated Bone from Core Biopsies

  6 months after augmentation during implant placement

• Bone Healing Parameters in Photobiomodulation vs Control Groups Assessed by CBCT and Histomorphometry

  6 months after bone augmentation

Study Arms (4)

Xenogeneic Bone Graft

EXPERIMENTAL

Patients undergoing bone regeneration procedures received a xenogeneic bone graft material prior to dental implant placement.

Procedure: Xenogeneic Bone Graft

Xenogeneic Bone Graft With Photobiomodulation

EXPERIMENTAL

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; Procedure: Low-Level Laser Therapy

Allogeneic Bone Graft

EXPERIMENTAL

Patients undergoing bone regeneration procedures received an allogeneic bone graft material prior to dental implant placement.

Procedure: Allogeneic Bone Graft

Allogeneic Bone Graft With Photobiomodulation

EXPERIMENTAL

Patients received an allogeneic bone graft material during bone regeneration procedures followed by adjunctive postoperative photobiomodulation therapy using low-level laser therapy (LLLT).

Procedure: Allogeneic Bone Graft; Procedure: Low-Level Laser Therapy

Interventions

Xenogeneic Bone Graft PROCEDURE

Xenogeneic bone graft material used for bone regeneration procedures prior to dental implant placement during sinus lift surgery.

Also known as: Xenograft

Xenogeneic Bone Graft; Xenogeneic Bone Graft With Photobiomodulation

Allogeneic Bone Graft PROCEDURE

Allogeneic bone graft material obtained from a human tissue bank and used for bone augmentation procedures prior to dental implant placement.

Also known as: Allograft

Allogeneic Bone Graft; Allogeneic Bone Graft With Photobiomodulation

Low-Level Laser Therapy PROCEDURE

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.

Also known as: Photobiomodulation LLLT

Allogeneic Bone Graft With Photobiomodulation; Xenogeneic Bone Graft With Photobiomodulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Innovation Center Wroclaw: lead
• Wrocław Medical University: collaborator

Study Sites (1)

MCIW - Wroclaw Medical Innovation Center

Wroclaw, Poland

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Transplantation, Heterologous; Transplantation, Homologous; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Paweł Kubasiewicz-Ross, dr hab.

  Department of Dental Surgery, Faculty of Dentistry, Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Histological and radiological evaluations were performed by investigators who were not involved in the surgical procedures and were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Deputy Head of the Specialist Outpatient Clinic, MCIW, Wroclaw Medical University

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 16, 2026
• Study Start: July 1, 2023
• Primary Completion: December 29, 2024
• Study Completion: December 29, 2024
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)