Alveolar Bone LossAnti-HLA BoneNCT07474857
Anti-HLA Antibodies After Bone Regeneration Surgery
A study testing Xenogeneic Bone Graft, Allogeneic Bone Graft and Low-Level Laser Therapy in people with Alveolar Bone Loss and Maxillary Sinus Bone Loss, run by Medical Innovation Center Wroclaw at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Maxillary Sinus Bone Loss
- What is being tested?
- Xenogeneic Bone Graft, Allogeneic Bone Graft and Low-Level Laser Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2023to 29 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Alveolar Bone Loss, Maxillary Sinus Bone Loss
- Being tested
- Xenogeneic Bone Graft, Allogeneic Bone Graft, Low-Level Laser Therapy
- Keywords
- Sinus Lift, Bone Regeneration, Anti-HLA Antibodies, Allogeneic Bone Graft, Xenogeneic Bone Graft, Photobiomodulation, Dental Implant Therapy
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenogeneic Bone GraftProcedure or surgery
Also called Xenograft
Xenogeneic bone graft material used for bone regeneration procedures prior to dental implant placement during sinus lift surgery.
Allogeneic Bone GraftProcedure or surgery
Also called Allograft
Allogeneic bone graft material obtained from a human tissue bank and used for bone augmentation procedures prior to dental implant placement.
Low-Level Laser TherapyProcedure or surgery
Also called Photobiomodulation LLLT
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.
| Study group | Role | What they receive |
|---|---|---|
| Xenogeneic Bone Graft | Experimental | Patients undergoing bone regeneration procedures received a xenogeneic bone graft material prior to dental implant placement. Receives: 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). Receives: 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. Receives: 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). Receives: Procedure: Allogeneic Bone Graft; Procedure: Low-Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months after bone augmentation
Secondary outcomes (3)
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)
Measured: 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
Measured: 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
Measured: 6 months after bone augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Jul 2023
- Primary completion29 Dec 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Innovation Center Wroclaw
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Principal investigator, Jakub Hadzik, Medical Innovation Center Wroclaw
- Investigators
- Paweł Kubasiewicz-Ross, dr hab., Principal investigator, Department of Dental Surgery, Faculty of Dentistry, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474857
- Sponsor's protocol ID
- 2024.Anty.HLA
- Acronym
- Anti-HLA Bone
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy considerations and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anti-HLA Antibody Development After Bone Regeneration Procedures and Analysis of Healing Processes
- ClinicalTrials.gov ID
- NCT07474857
- Acronym / sponsor ID
- Anti-HLA Bone / 2024.Anty.HLA
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical Innovation Center WroclawUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Xenogeneic Bone Graft | Experimental | Procedure: Xenogeneic Bone GraftPatients undergoing bone regeneration procedures received a xenogeneic bone graft material prior to dental implant placement. |
| Xenogeneic Bone Graft With Photobiomodulation | Experimental | Procedure: Xenogeneic Bone Graft, Procedure: Low-Level Laser TherapyPatients received a xenogeneic bone graft material during bone regeneration procedures followed by adjunctive postoperative photobiomodulation therapy using low-level laser therapy (LLLT). |
| Allogeneic Bone Graft | Experimental | Procedure: Allogeneic Bone GraftPatients undergoing bone regeneration procedures received an allogeneic bone graft material prior to dental implant placement. |
| Allogeneic Bone Graft With Photobiomodulation | Experimental | Procedure: Allogeneic Bone Graft, Procedure: Low-Level Laser TherapyPatients received an allogeneic bone graft material during bone regeneration procedures followed by adjunctive postoperative photobiomodulation therapy using low-level laser therapy (LLLT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Systemic diseases affecting bone healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenogeneic Bone GraftAlso: XenograftXenogeneic bone graft material used for bone regeneration procedures prior to dental implant placement during sinus lift surgery. | Procedure or surgery | Xenogeneic Bone Graft, Xenogeneic Bone Graft With Photobiomodulation |
| Allogeneic Bone GraftAlso: AllograftAllogeneic bone graft material obtained from a human tissue bank and used for bone augmentation procedures prior to dental implant placement. | Procedure or surgery | Allogeneic Bone Graft, Allogeneic Bone Graft With Photobiomodulation |
| Low-Level Laser TherapyAlso: Photobiomodulation LLLTPostoperative 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. | Procedure or surgery | Allogeneic Bone Graft With Photobiomodulation, Xenogeneic Bone Graft With Photobiomodulation |
Primary outcome
Change in Anti-HLA Antibody Levels Measured by Luminex Single-Antigen Bead Assay
Time frame: 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.
3 secondary outcomes
Radiographic bone regeneration in vertical bone height
Time frame: 6 months after bone augmentation
Histomorphometric Evaluation of Regenerated Bone from Core Biopsies
Time frame: 6 months after augmentation during implant placement
Bone Healing Parameters in Photobiomodulation vs Control Groups Assessed by CBCT and Histomorphometry
Time frame: 6 months after bone augmentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy considerations and institutional data protection policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Kubasiewicz-Ross, dr hab. principal investigator
Department of Dental Surgery, Faculty of Dentistry, Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xenogeneic Bone Graft, Allogeneic Bone Graft and Low-Level Laser Therapy in people with Alveolar Bone Loss and Maxillary Sinus Bone Loss, run by Medical Innovation Center Wroclaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anti-HLA Antibody Levels Measured by Luminex Single-Antigen Bead Assay (time frame: Baseline and 6 months after bone augmentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.