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

N/ARecruitingNCT07419269

Medical University of Graz26 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alveolar Bone Loss

Interventions

Alveolar socket preservation with graft and flap surgery

Partially edentulous patients in need of implant therapy and presenting an insufficient bone volume (horizontal ridge width \<5mm) to allow placing a standard diameter implant defect-free in a prosthetically ideal position will be included. In the control group, the blocks will be adapted to the defect site morphology. With a small drill, holes for fixation will be prepared and the bone blocks will be immobilized with one or two screws. Subsequently, a layer of bone particles will be applied if needed to cover the autogenous bone and to fill up voids.

allogenic bone block augmentationPROCEDURE

Partially edentulous patients in need of implant therapy and presenting an insufficient bone volume (horizontal ridge width \<5mm) to allow placing a standard diameter implant defect-free in a prosthetically ideal position. Based on CT/CBCT scans of the patient, the allogenic bone block has already been virtually designed using 3D CAD/CAM technology prior to surgery. The individually milled bone graft Botiss maxgraft® bonebuilder (allogenic bone block), optional addition of MinerOss® A (allogenic bone granules) will then be covered with Argonaut® (porcine collagenbased membrane).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

ridge width gain in mm

* Clinical bone ridge width gain * Radiological bone ridge width gain

Time frame: at screening after augementation (= day 0) 180 days past augmentation (=implantation) 1 year after 2nd stage surgery 2 years after 2nd stage surgery 3 years after 2nd stage surgery 4 years after 2nd stage surgery 5 years after 2nd stage surgery