Alveolar Bone LossIndiALLONCT07419269
Comparison of Customized Allogenic Versus Autogenous Bone Block Graft for Alveolar Ridge Augmentation
A study testing Alveolar socket preservation with graft and flap surgery and allogenic bone block augmentation in people with Alveolar Bone Loss, run by Medical University of Graz at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Alveolar socket preservation with graft and flap surgery and allogenic bone block augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2025to 1 Aug 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics, Medical University of Graz
Graz, Styria, 8010
Michael Payer, Assoz.Prof., +4331638580659, mi.payer@medunigraz.at
About this study
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).
- Conditions
- Alveolar Bone Loss
- Being tested
- Alveolar socket preservation with graft and flap surgery, allogenic bone block augmentation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar socket preservation with graft and flap surgeryProcedure or 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 or 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).
| Study group | Role | What they receive |
|---|---|---|
| individualized allogenic bone block alveolar ridge augmentation | Experimental | Not described Receives: Procedure: allogenic bone block augmentation |
| autologous bone | Active comparator | Not described Receives: Procedure: Alveolar socket preservation with graft and flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
ridge width gain in mm
- Clinical bone ridge width gain
- Radiological bone ridge width gain
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419269
- Sponsor's protocol ID
- 36-016 ex 23/24
- Other IDs
- 1638-2021
- Acronym
- IndiALLO
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Customized Allogenic Versus Autogenous Bone Block Graft for Alveolar Ridge Augmentation
- ClinicalTrials.gov ID
- NCT07419269
- Acronym / sponsor ID
- IndiALLO / 36-016 ex 23/24
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 Aug 2032 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individualized allogenic bone block alveolar ridge augmentation | Experimental | Procedure: allogenic bone block augmentation |
| autologous bone | Active comparator | Procedure: Alveolar socket preservation with graft and flap surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar socket preservation with graft and flap 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. | Procedure or surgery | autologous bone |
| allogenic bone block augmentationPartially 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). | Procedure or surgery | individualized allogenic bone block alveolar ridge augmentation |
Primary outcome
ridge width gain in mm
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
* Clinical bone ridge width gain * Radiological bone ridge width gain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar socket preservation with graft and flap surgery and allogenic bone block augmentation in people with Alveolar Bone Loss, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Payer, Assoz.Prof. (+4331638580659, mi.payer@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ridge width gain in mm (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.