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

Semmelweis University

Status: Not yet enrolling

Conditions: Edentulous Alveolar Ridge; Edentulous Alveolar Ridge Atrophy

Treatments: Diagnostic Test: post operative cone beam computer tomography (CBCT); Diagnostic Test: preoperative cone beam computered tomography (CBCT); Procedure: Bone augmnentation using freeze-dried allograft block; Procedure: Dental implant placement; Procedure: Fixed dental prosthesis (FDP) fabrication; Procedure: Bone augmentation using an autologous bone block; Diagnostic Test: Bone core biopsy; Device: Bone grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT07104370

SEDCD45

Details and patient eligibility

About

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 prior to or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for the reconstruction of 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 micoarchitecture of the augmented bone depending on the bone graft material applied,
• to evalute the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• over 18 years old
• require lateral augmentation for implant rehabilitation

Exclusion criteria

• Smoking
• 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 contraindicating surgery
• Use of medications affecting bone metabolism (steroids, antiresorptive medications such as bisphosphonates, RANKL inhibitor antibodies, VEGF antagonists)
• Psychiatric disorders contraindicating implant rehabilitation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Freeze-dried allograft bone block

Experimental group

Description:

A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.

Treatment:

Device: Bone grafting

Diagnostic Test: Bone core biopsy

Procedure: Fixed dental prosthesis (FDP) fabrication

Procedure: Dental implant placement

Diagnostic Test: post operative cone beam computer tomography (CBCT)

Diagnostic Test: preoperative cone beam computered tomography (CBCT)

Procedure: Bone augmnentation using freeze-dried allograft block

Autogenous bone block

Active Comparator group

Description:

An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw.

Treatment:

Diagnostic Test: Bone core biopsy

Procedure: Bone augmentation using an autologous bone block

Procedure: Fixed dental prosthesis (FDP) fabrication

Procedure: Dental implant placement

Diagnostic Test: post operative cone beam computer tomography (CBCT)

Diagnostic Test: preoperative cone beam computered tomography (CBCT)