About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Alveolar socket preservation with graft and flap surgery
Procedure/SurgeryPartially 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 augmentation
Procedure/SurgeryPartially 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).
Treatment groups
Trial outcomes
Primary outcomes
ridge width gain in mm
* Clinical bone ridge width gain * Radiological bone ridge width gain
Sponsors and contacts
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