None listed
Conditions
Brief summary
The objective of this randomized controlled clinical trial is to compare the efficacy of a patient specific 3D-printed manufactured medical grade polycaprolactone mesh with a collagen membrane that are loaded with particulate anorganic porcine bone mineral and autogenous bone in the reconstruction of alveolar ridge defects. Lay public hypothesis: We anticipate no significant differences when using customized 3D-printed polymer (polycaprolactone) mesh or the current technique of using animal derived collagen membranes trimmed chair-side to reconstruct lost jaw bone. The trial will report results for a extensive range of outcomes including; graft volume, post-operative recovery/morbidity, implant feasibility, histology, peri-implant parameters and patient reported outcomes
Interventions
The trial compare effectiveness of the using a 3D printed patient specific polycaprolactone (PCL) (test) mesh versus a collagen membrane (control) when combined with a a composite graft composed of particulate anorganic porcine bone mineral (APBM) and autogenous bone (AB) in a 1:1 ratio for alveolar ridge augmentation (replacing lost jaw bone). What occurs during these interventions: There are two surgical interventions. The first is alveolar ridge augmentation, which is performed to reconstruct the lost jaw bone required for dental implant placement. This surgery will be performed by experienced specialist clinicians (Periodontists) with more than 17 years experience in complex alveolar bone reconstructive surgery. The procedure involves achieving access to the bone defect via a mucoperiosteal flap. Autogenous bone harvesting is performed from the retro-molar region and mixed with porcine bone mineral then loaded into the defect and covered using a patient specific 3D printed polymer (PCL) scaffold (test group) or a collagen membrane (control). This is secured to the jaw bone then covered by the flap. Surgery will be performed in a private practice and will be 90-120min in duration. The second intervention takes place 8 months later, and takes approximately 1 hour to complete. It involves elevating a mucoperiosteal flap then creating an osteotomy of specific dimensions to allow the placement of the dental implant. The flap is then replaced and allowed to heal for a further 12 weeks before the patient continues the prosthetic phase of treatment with their referring clinicians independent of the study. Adherence to intervention will be assessed by reviewing completed case report forms (CRFs).
Sponsors
Study design
Eligibility
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 2. Adequate plaque control (FM plaque and BOP scores less than or equal to 25%) at study baseline 3. Dental implant placement replacing 1-4 teeth in a partially dentate patient 4. Horizontal alveolar ridge deficiency preventing dental implant placement in a prosthetically driven position or with an unstable defect morphology necessitating staged bone augmentation (class-3, 4) 5. If bilateral ridge augmentation is required, only one ridge will be randomly selected and used for the purposes of this study 6. Teeth at the surgical site which require removal are extracted a minimum of 12 weeks prior to ridge augmentation 7. 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. 8. 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 less than or equal to 5mm
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