RecruitingACTRN12626000156381

Regenerating lost jaw bone using patient specific 3D-printed resorbable polycaprolactone mesh versus a titanium mesh

A randomized controlled clinical evaluating the efficacy of patient specific 3D-printed resorbable polycaprolactone mesh versus titanium mesh in alveolar ridge augmentation

Sponsor

University of Queensland

Enrollment

60 participants

Start Date

Aug 8, 2025

Study Type

Interventional

Conditions

Dental implant placement Bone loss in the jaw

Summary

The purpose of this clinical trial is to compare a custom made (3D-printed) biodegradable (polymer called polycaprolactone or PCL) mesh with a custom made (3D-printed) metal (titanium or Ti) mesh in the reconstruction of jaw bone deficiency. Currently there is no ideal technology for the treatment of large or complex jaw bone deficiencies. We have developed a biodegradable, customizable, 3D printed mesh to regenerate alveolar (jaw) bone (the part of the skull bone that houses the teeth) to allow for dental implant placement. The use of a biodegradable, customized and accurate device may lead to advantages such as reduced surgical time, improved patient recovery and improved ridge contour when compared to the control device. This specific material called Polycaprolactone (PCL) is already approved in Australia for use in sutures, screws and dermal fillers. However, it is not approved to treat jaw bone deficiency. Therefore, it is an experimental treatment for jaw bone regeneration.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at a new way to rebuild jaw bone that has been lost — for example, after a tooth extraction or due to gum disease — so that dental implants can be placed. Researchers are comparing two types of custom-made, 3D-printed mesh devices: one made from a biodegradable plastic called polycaprolactone (PCL) that dissolves in the body over time, and one made from titanium, which is a metal that stays in the body permanently. Both meshes are shaped specifically for each patient's anatomy. The PCL mesh is already approved in Australia for other uses (like sutures and fillers), but using it to regrow jaw bone is experimental. The hope is that the dissolving mesh will guide new bone to grow, reduce surgery time, and lead to better recovery compared to the metal mesh. After the bone has grown, dental implants can be placed. You may be eligible if you are aged 18–65, are generally healthy, need dental implants to replace up to 6 teeth, and have a jaw bone defect that prevents implant placement. You must also not smoke heavily, not be pregnant, and not have conditions that interfere with bone healing.

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Interventions

The aim of this clinical trial is to compare the efficacy of a patient specific 3D-printed manufactured medical grade polycaprolactone (PCL) mesh with 3D-printed manufactured titanium (Ti) mesh that are loaded with particulate anorganic bovine bone mineral (ABBM) and autogenous bone (AB) combined with injectable platelet rich fibrin (iPRF) in the reconstruction of alveolar ridge defects. The bone regeneration will take place under GA by experienced periodontists. This can take up to 3 hours. Healing period will take up to three months whereby cone beam computed tomography scan (CBCT) will be used to verify the regenerated bone. Dental implant will then be placed under LA by either the same periodontists or periodontal postgraduate students (under specialist periodontist supervision) at the University of Queensland. After three months of healing, osseointegration will be verified and the implants can be restored by private prosthodontist, private dentist or prosthodontic postgraduate students (under specialist prosthodontist supervision) at the University of Queensland. Restoration at baseline will be collected within four weeks of restoration delivery and a year after restoration delivery. Overall duration of treatment will be three parts over 6-8 months and final appointment will be 12 months from the restoration delivery date. Adherence monitoring will be via surgical notes and patient consent form obtained prior to patient entering the project.

Locations(1)

QLD, Australia

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ACTRN12626000156381