Assessment of Anti-HLA Antibody Development After Bone Regeneration Procedures and Analysis of Healing Processes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Anti-HLA Antibody Levels Measured by Luminex Single-Antigen Bead Assay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Histological and radiological evaluations were performed by investigators who were not involved in the surgical procedures and were blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Xenogeneic Bone Graft
Patients undergoing bone regeneration procedures received a xenogeneic bone graft material prior to dental implant placement.
干预措施: Xenogeneic Bone Graft (Procedure)
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).
干预措施: Xenogeneic Bone Graft (Procedure)
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).
干预措施: Low-Level Laser Therapy (Procedure)
Allogeneic Bone Graft
Patients undergoing bone regeneration procedures received an allogeneic bone graft material prior to dental implant placement.
干预措施: Allogeneic Bone Graft (Procedure)
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).
干预措施: Allogeneic Bone Graft (Procedure)
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).
干预措施: Low-Level Laser Therapy (Procedure)
结局指标
主要结局
Change in Anti-HLA Antibody Levels Measured by Luminex Single-Antigen Bead Assay
时间窗: Baseline and 6 months after bone augmentation
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.
次要结局
- 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)
研究者
Jakub Hadzik
Associate Professor, Deputy Head of the Specialist Outpatient Clinic, MCIW, Wroclaw Medical University
Medical Innovation Center Wroclaw
