Comparison of Customized Allogenic Versus Autogenous Bone Block Graft for Alveolar Ridge Augmentation

Comparison of Customized Allogenic Versus Autogenous Bone Block Graft for Alveolar Ridge Augmentation

The aim of this study is to determine whether jawbone augmentations using allogeneic and autogenous bone blocks lead to comparable three-dimensional clinical and radiological outcomes.

In addition, the study seeks to investigate whether there are differences regarding safety, biocompatibility, complications, and PROMs.

Furthermore, it aims to clarify whether differences exist between the two groups with respect to implant condition (one year after implantation and during annual follow-ups for up to five years).

INCLUSION CRITERIA

• 1-4 missing teeth that need to be replaced with dental implants
• Bone ridge width insufficient for dental implant placement; <5 mm of width as measured in a cone beam computed tomography at the ideal prosthetic position
• Medically healthy with no known allergies to antibiotics
• Non-smoker or light smoker (< 10) or previous smoker who had quit for 5 years or more
• Periodontal health, as confirmed by clinical examination (Full mouth bleeding score and full mouth plaque score < 25%) and at least one neighboring natural tooth to the defect site(s)
• Age of 18 or above

EXCLUSION CRITERIA

• All contraindications against implant treatment or augmentative procedures (e.g., advanced systemic diseases, corticosteroid medication, immunodeficiency, pregnancy, intention to become pregnant, breastfeeding, lack of safe contraception)
• Treatments or diseases that may have an effect on bone turnover or the bone itself or non-mineralized tissue metabolism (e.g., bisphosphonates or local radiotherapy, skeletal immaturity)
• Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone diseases
• Any active malignancy or patient undergoing treatment for a malignancy Study protocol: IndiALLO Version 4/19.03.2025 Page 9 von 32
• Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product
• Persistent compartment syndrome or neurovascular residua of compartment syndrome