None listed
Conditions
Brief 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.
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. He
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.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals aged between 18 and 65 years, medically healthy or with mild controlled systemic disease, able to undergo oral surgical procedures under local or general anaesthesia (ASA I and II; American Society of Anesthesiologists, Schaumburg, Illinois, USA). 2. Adequate plaque control (FM plaque and BOP scores less than or equal to 25%) at study baseline 3. Dental implant placement replacing up to 6 teeth in a partially dentate patient 4. Vertical alveolar ridge defect (with or without a horizontal component) of =2mm or combined buccal and palatal/lingual horizontal defects in the region of interest preventing dental implant placement in a prosthetically driven position or with an unstable defect morphology necessitating staged bone augmentation. 5. Teeth at the surgical site which require removal are extracted a minimum of 12 weeks prior to ridge augmentation 6. Adequate soft tissue profile for staged ridge augmentation. This includes a minimum zone of 2mm of keratinized gingival tissue at the buccal aspect of the surgical zone and adequate tissue thickness. Thickness is assessed by transparency of periodontal probe through the gingival margin of the adjacent teeth. Inadequate tissue parameters can be repaired prior to trial participation. 7. Treated and stable periodontal disease as assessed by specialist Periodontists with stability defined as having a full mouth bleeding score of less than or equal to 20% and no sites of residual periodontal probing depth greater than 5mm (Lang & Tonetti, 2003).
Exclusion criteria
1. Pregnancy at the time of recruitment 2. Alcoholism or chronic drug abuse 3. Patients who smoke more than 10 cigarettes per day 4. Medications or pathology which interferes with bone formation 5. History of local radiation therapy 6. Severe parafunction 7. Extensive metallic restorations in region of interest especially post-core restorations 8. Presence of dental implant adjacent to region of interest 9. Oral mucosal disease such as Lichen Planus
Outcome results
None listed