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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Graz

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Alveolar socket preservation with graft and flap surgery

    Procedure/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 augmentation

    Procedure/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. 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

26 Participants
are divided into 2 treatment groups
Group A: individualized allogenic bone block alveolar ridge augmentationExperimental treatment 1 intervention
Group B: autologous boneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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