Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws

Summary

After tooth loss, the alveolar ridge undergoes various modeling and remodeling processes, resulting in overall bone resorption. In case of extensive alveolar atrophy, bone volume must be restored before or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for reconstructing severe bone resorption is block bone augmentation.

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.

Conditions

• Edentulous Alveolar Ridge
• Edentulous Alveolar Ridge Atrophy

Interventions

PROCEDURE

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.

PROCEDURE

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

post-operative cone beam computed tomography (CBCT)

Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation.

PROCEDURE

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.

DIAGNOSTIC_TEST

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.

PROCEDURE

Fixed dental prosthesis (FDP) fabrication

After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants.

DEVICE

Bone grafting

Freeze-dried bone allograft block

Sponsors & Collaborators

• Semmelweis University

  lead OTHER

Principal Investigators

• Csilla Szerencse, DMD, MDS · Department of Public Dental Health Semmelweis University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-29

Primary Completion

2028-09-01

Completion

2033-09-01

Countries

• Hungary

Study Locations