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

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 Overview

• Status: Recruiting
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: allogenic bone block augmentation; Procedure: Alveolar socket preservation with graft and flap surgery

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Payer, Assoz.Prof.; Phone Number: +4331638580659; Email: mi.payer@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Recruiting
      • Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics, Medical University of Graz
      • Contact: Michael Payer, Assoz.Prof.; Phone Number: +4331638580659; Email: mi.payer@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: individualized allogenic bone block alveolar ridge augmentation	Procedure: allogenic bone block augmentation; 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).
Active Comparator: autologous bone	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ridge width gain in mm	Clinical bone ridge width gain; Radiological bone ridge width gain	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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 1, 2032

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss; Surgical Procedures, Operative; Transplantation
• Other Study ID Numbers: 36-016 ex 23/24; 1638-2021 (Other Grant/Funding Number: ITI Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No