None listed
Conditions
Brief summary
The use of pre-fabricated, customized and bioresorbable medical grade scaffolds is a significant development in this field of tissue engineering. Medical grade polycaprolactone (PCL) is a highly biocompatible and completely bioresorbable polymer. These scaffolds have been shown to be dimensionally accurate and stable, adaptable to a range of defects and conducive for bone regeneration. These scaffolds, are yet to be clinically assessed clinically. The objective of this proof of principle study is to report on the efficacy of a 3D printed custom manufactured medical grade polycaprolactone (PCL) scaffold that is loaded with anorganic bovine bone mineral (ABBM) and particulate autogenous bone (AB) in reconstruction of alveolar ridge defects.
Interventions
Single arm clinical trial assessing the efficacy of a 3D printed custom manufactured medical grade polycaprolactone (PCL) scaffold that is loaded with anorganic bovine bone mineral (ABBM) and particulate autogenous bone (AB) in reconstruction of alveolar ridge defects for the purpose of dental implant rehabilitation. This involves two surgical procedures; the first to reconstruct the alveolar ridge followed by dental implant placement 9 months later and finally prosthetic rehabilitation 3 months
Single arm clinical trial assessing the efficacy of a 3D printed custom manufactured medical grade polycaprolactone (PCL) scaffold that is loaded with anorganic bovine bone mineral (ABBM) and particulate autogenous bone (AB) in reconstruction of alveolar ridge defects for the purpose of dental implant rehabilitation. This involves two surgical procedures; the first to reconstruct the alveolar ridge followed by dental implant placement 9 months later and finally prosthetic rehabilitation 3 months after implant placement. This treatment will be provided by a well established research group including clinicians (specialist periodontists) and scientists at a university and specialist private practice. The surgical procedures will be carried out in day surgery under general anaesthesia. The initial procedure will take approximately 2 hours. The following procedure will take 1-2 hours. Both surgical procedures will be followed by post-surgical care at 2 weeks. The prosthetic phase of treatment will carried out by independent restorative clinicians in a private practice setting over typically 3 1 hour appointments. Throughout these clinical procedures the patient is expected to carry out post-surgical home care and then standard oral home care, once restored.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Individuals were at least 18 years of age, 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). • Adequate plaque control (FM plaque and BOP scores equal to or greater than 25%) at study baseline • Dental implant replacement of multiple units (2 or more units) in a partially dentate patient • Alveolar ridge deficiency preventing dental implant placement in a prosthetically driven position with the following characteristics: absence of the buccal wall equal to or greater than 50% of the prospective implant length with or without loss of vertical height (2/4, 3/4 or 4/4 defect) (Terheyden 2010 ) • If bilateral ridge augmentation is required, only one ridge will be randomly selected and used for the purposes of this study. • Teeth at the surgical site which require removal are extracted a minimum of 12 weeks prior to ridge augmentation • A minimum zone of 2mm of gingival tissue in buccal aspect of the surgical zone • Treated and stable periodontal disease as assessed by specialist Periodontists (JA & SI) with stability defined as having a full mouth bleeding score of equal to or greater than 20% and no sites of residual periodontal probing depth equal to or greater than 5mm (Lang & Tonetti 2003).
Exclusion criteria
• Pregnancy at the time of recruitment • Alcoholism or chronic drug abuse • Patients who smoke more than 10 cigarettes per day • Medications or pathology which interferes with bone formation • History of local radiation therapy • Severe parafunction • Extensive metallic restorations in region of interest especially post-core restorations • Presence of dental implant adjacent to region of interest • Oral mucosal disease such as Lichen Planus
Outcome results
None listed