Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws
NCT ID: NCT07104370
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-09-29
2033-09-01
Brief Summary
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Due to its biological properties, autologous bone is considered the "gold standard" among bone graft materials, as it possesses osteoinductive, osteoconductive, and osteogenic properties.
The advantages of using allografts over autologous bone grafts include reduced postoperative morbidity, decreased surgical time, and the absence of anatomical limitations regarding the amount of bone that can be harvested. The disadvantage of allografts is the loss of viable osteogenic cells and osteoinductive factors during processing.
The aim of the study is:
* to compare the success of the bone augmentation surgery depending on whether freeze-dried bone allograft blocks or autologous bone blocks are used,
* compare the microarchitecture of the augmented bone depending on the bone graft material applied,
* to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Freeze-dried allograft bone block
A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.
Bone augmentation using freeze-dried allograft block
* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap.
* In the test group, a freeze-dried allograft bone block is prepared to the required size using rotary instruments.
* The block is fixed to the recipient site with two screws.
* The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures.
* Sutures are removed two weeks postoperatively.
* All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In case of amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided.
* Patients do not wear temporary prostheses during the healing period.
preoperative cone beam computed tomography (CBCT)
• Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region.
post-operative cone beam computed tomography (CBCT)
Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation.
Dental implant placement
Following the 3-month-long healing period following bone augmentation, dental implants are placed non-submerged in the augmented bone under local anaesthesia.
Bone core biopsy
At the time of dental implant placement, a rotary instrument is used to harvest a bone core biopsy sample from the augmented bone. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.
Fixed dental prosthesis (FDP) fabrication
After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants.
Bone grafting
Freeze-dried bone allograft block
Autogenous bone block
An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw.
Bone augmentation using an autologous bone block
* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap.
* In the control group, an autologous bone block graft is harvested from the retromolar donor area using rotary instruments and piezoelectric surgery.
* The block is fixed to the recipient site with two screws.
* The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures.
* Sutures are removed two weeks postoperatively.
* All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In the case of an amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided.
* Patients do not wear temporary prostheses during the healing period.
preoperative cone beam computed tomography (CBCT)
• Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region.
post-operative cone beam computed tomography (CBCT)
Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation.
Dental implant placement
Following the 3-month-long healing period following bone augmentation, dental implants are placed non-submerged in the augmented bone under local anaesthesia.
Bone core biopsy
At the time of dental implant placement, a rotary instrument is used to harvest a bone core biopsy sample from the augmented bone. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.
Fixed dental prosthesis (FDP) fabrication
After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants.
Interventions
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Bone augmentation using an autologous bone block
* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap.
* In the control group, an autologous bone block graft is harvested from the retromolar donor area using rotary instruments and piezoelectric surgery.
* The block is fixed to the recipient site with two screws.
* The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures.
* Sutures are removed two weeks postoperatively.
* All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In the case of an amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided.
* Patients do not wear temporary prostheses during the healing period.
Bone augmentation using freeze-dried allograft block
* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap.
* In the test group, a freeze-dried allograft bone block is prepared to the required size using rotary instruments.
* The block is fixed to the recipient site with two screws.
* The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures.
* Sutures are removed two weeks postoperatively.
* All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In case of amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided.
* Patients do not wear temporary prostheses during the healing period.
preoperative cone beam computed tomography (CBCT)
• Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region.
post-operative cone beam computed tomography (CBCT)
Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation.
Dental implant placement
Following the 3-month-long healing period following bone augmentation, dental implants are placed non-submerged in the augmented bone under local anaesthesia.
Bone core biopsy
At the time of dental implant placement, a rotary instrument is used to harvest a bone core biopsy sample from the augmented bone. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.
Fixed dental prosthesis (FDP) fabrication
After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants.
Bone grafting
Freeze-dried bone allograft block
Eligibility Criteria
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Inclusion Criteria
* require lateral augmentation for implant rehabilitation
Exclusion Criteria
* Pregnancy
* Poor oral hygiene
* Failure to attend follow-up visits
* Therapeutic-dose irradiation to the head and neck region
* Local bone tumors, cysts, or inflammatory processes
* Decompensated systemic diseases contraindicate surgery
* Use of medications affecting bone metabolism (steroids, antiresorptive medications such as bisphosphonates, RANKL inhibitor antibodies, VEGF antagonists)
* Psychiatric disorders contraindicate implant rehabilitation
18 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Dr. Szerencse Csilla
Dentist, oral surgeon
Principal Investigators
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Csilla Szerencse, DMD, MDS
Role: PRINCIPAL_INVESTIGATOR
Department of Public Dental Health Semmelweis University
Locations
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Semmelweis University Department of Public Dental Health
Budapest, Hungary, Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SEDCD45
Identifier Type: -
Identifier Source: org_study_id
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