Crotone, Italy
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Idle M.R.,Royal Shrewsbury Hospital | Lowe D.,University of Liverpool | Rogers S.N.,University of Liverpool | Sidebottom A.J.,Maxillofacial Unit | And 2 more authors.
British Journal of Oral and Maxillofacial Surgery | Year: 2014

Our goal is to establish the long-term collection of data on temporomandibular joint replacement from all centres in the UK where this is done. Currently, 16 surgeons have been identified, and 13 of them had entered data when this paper was being prepared. Data are entered online through the Snap Survey and then analysed annually. We report on 402 patients (332 (83%) female and 70 (17%) male) who had 577 joints inserted between 1994 and 2012. The main diagnoses that resulted in total joint replacement were osteoarthritis, failed operation, ankylosis, and seronegative arthritis. Preoperatively, the median (IQR) maximal incisal opening was 20 (15-26) mm (mean 20) and the median pain scores on the visual analogue scale (VAS 0-10) were 8 for both joints. The median (IQR) baseline dietary score (liquid 0 - solid 10) was 4 (3-6). A total of 173 (43%) patients had had one or more open procedure(s) before total replacement, 177 (44%) had not had open operation, and 52 (13%) had no data entered. The 3 primary systems used were the TMJ Concepts System (Ventura, USA), the Biomet System (Biomet/Lorenz Microfixation, Jacksonville, USA), and the Christensen System (TMJ Implants, Golden, USA). The median (IQR) duration of inpatient stay was 3 (2-4) days (mean 3). Follow-up data will be collected to assess patient recorded outcome measures (PROM) and objective measurements of total joint replacements in the UK from 1994 onwards. © 2013 The British Association of Oral and Maxillofacial Surgeons.


PubMed | Queen Elizabeth Hospital, Royal Shrewsbury Hospital, University of Liverpool, Maxillofacial Unit and Bradford Teaching Hospitals
Type: Journal Article | Journal: The British journal of oral & maxillofacial surgery | Year: 2014

Our goal is to establish the long-term collection of data on temporomandibular joint replacement from all centres in the UK where this is done. Currently, 16 surgeons have been identified, and 13 of them had entered data when this paper was being prepared. Data are entered online through the Snap Survey and then analysed annually. We report on 402 patients (332 (83%) female and 70 (17%) male) who had 577 joints inserted between 1994 and 2012. The main diagnoses that resulted in total joint replacement were osteoarthritis, failed operation, ankylosis, and seronegative arthritis. Preoperatively, the median (IQR) maximal incisal opening was 20 (15-26)mm (mean 20) and the median pain scores on the visual analogue scale (VAS 0-10) were 8 for both joints. The median (IQR) baseline dietary score (liquid 0 - solid 10) was 4 (3-6). A total of 173 (43%) patients had had one or more open procedure(s) before total replacement, 177 (44%) had not had open operation, and 52 (13%) had no data entered. The 3 primary systems used were the TMJ Concepts System (Ventura, USA), the Biomet System (Biomet/Lorenz Microfixation, Jacksonville, USA), and the Christensen System (TMJ Implants, Golden, USA). The median (IQR) duration of inpatient stay was 3 (2-4) days (mean 3). Follow-up data will be collected to assess patient recorded outcome measures (PROM) and objective measurements of total joint replacements in the UK from 1994 onwards.


PubMed | Maxillofacial Unit, University of Bari, Tecnologica Research Institute Crotone, University Pierre and Marie Curie and 3 more.
Type: | Journal: Frontiers in physiology | Year: 2014

The extracellular matrix (ECM) of decellularized organs possesses the characteristics of the ideal tissue-engineering scaffold (i.e., histocompatibility, porosity, degradability, non-toxicity). We previously observed that the muscle acellular scaffold (MAS) is a pro-myogenic environment in vivo. In order to determine whether MAS, which is basically muscle ECM, behaves as a myogenic environment, regardless of its location, we analyzed MAS interaction with both muscle and non-muscle cells and tissues, to assess the effects of MAS on cell differentiation. Bone morphogenetic protein treatment of C2C12 cells cultured within MAS induced osteogenic differentiation in vitro, thus suggesting that MAS does not irreversibly commit cells to myogenesis. In vivo MAS supported formation of nascent muscle fibers when replacing a muscle (orthotopic position). However, heterotopically grafted MAS did not give rise to muscle fibers when transplanted within the renal capsule. Also, no muscle formation was observed when MAS was transplanted under the xiphoid process, in spite of the abundant presence of cells migrating along the laminin-based MAS structure. Taken together, our results suggest that MAS itself is not sufficient to induce myogenic differentiation. It is likely that the pro-myogenic environment of MAS is not strictly related to the intrinsic properties of the muscle scaffold (e.g., specific muscle ECM proteins). Indeed, it is more likely that myogenic stem cells colonizing MAS recognize a muscle environment that ultimately allows terminal myogenic differentiation. In conclusion, MAS may represent a suitable environment for muscle and non-muscle 3D constructs characterized by a highly organized structure whose relative stability promotes integration with the surrounding tissues. Our work highlights the plasticity of MAS, suggesting that it may be possible to consider MAS for a wider range of tissue engineering applications than the mere replacement of volumetric muscle loss.


Sharples L.,University of Leeds | Sharples L.,Medical Research Council Biostatistics Unit | Sharples L.,Papworth Hospital NHS Foundation Trust | Glover M.,Brunel University | And 13 more authors.
Health Technology Assessment | Year: 2014

Background: Obstructive sleep apnoea–hypopnoea (OSAH) causes excessive daytime sleepiness (EDS), impairs quality of life (QoL) and increases cardiovascular disease and road traffic accident risks. Continuous positive airway pressure (CPAP) treatment is clinically effective but undermined by intolerance, and its cost-effectiveness is borderline in milder cases. Mandibular advancement devices (MADs) are another option, but evidence is lacking regarding their clinical effectiveness and cost-effectiveness in milder disease.Objectives: (1) Conduct a randomised controlled trial (RCT) examining the clinical effectiveness and cost-effectiveness of MADs against no treatment in mild to moderate OSAH. (2) Update systematic reviews and an existing health economic decision model with data from the Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and newly published results to better inform long-term clinical effectiveness and cost-effectiveness of MADs and CPAP in mild to moderate OSAH.TOMADO: A crossover RCT comparing clinical effectiveness and cost-effectiveness of three MADs: self-moulded [SleepPro 1™ (SP1); Meditas Ltd, Winchester, UK]; semibespoke [SleepPro 2™ (SP2); Meditas Ltd, Winchester, UK]; and fully bespoke [bespoke MAD (bMAD); NHS Oral-Maxillofacial Laboratory, Addenbrooke’s Hospital, Cambridge, UK] against no treatment, in 90 adults with mild to moderate OSAH. All devices improved primary outcome [apnoea–hypopnoea index (AHI)] compared with no treatment: relative risk 0.74 [95% confidence interval (CI) 0.62 to 0.89] for SP1; relative risk 0.67 (95% CI 0.59 to 0.76) for SP2; and relative risk 0.64 (95% CI 0.55 to 0.76) for bMAD (p < 0.001). Differences between MADs were not significant. Sleepiness [as measured by the Epworth Sleepiness Scale (ESS)] was scored 1.51 [95% CI 0.73 to 2.29 (SP1)] to 2.37 [95% CI 1.53 to 3.22 (bMAD)] lower than no treatment (p < 0.001), with SP2 and bMAD significantly better than SP1. All MADs improved disease-specific QoL. Compliance was lower for SP1, which was unpopular at trial exit. At 4 weeks, all devices were cost-effective at £20,000/quality-adjusted life-year (QALY), with SP2 the best value below £39,800/QALY.Meta-analysis: A MEDLINE, EMBASE and Science Citation Index search updating two existing systematic reviews (one from November 2006 and the other from June 2008) to August 2013 identified 77 RCTs in adult OSAH patients comparing MAD with conservative management (CM), MADs with CPAP or CPAP with CM. MADs and CPAP significantly improved AHI [MAD −9.3/hour (p v 0.001); CPAP −25.4/hour (p < 0.001)]. Effect difference between CPAP and MADs was 7.0/hour (p < 0.001), favouring CPAP. No trials compared CPAP with MADs in mild OSAH. MAD and CPAP reduced the ESS score similarly [MAD 1.6 (p v 0.001); CPAP 1.6 (p < 0.001)].Long-term cost-effectiveness: An existing model assessed lifetime cost–utility of MAD and CPAP in mild to moderate OSAH, using the revised meta-analysis to update input values. The TOMADO provided utility estimates, mapping ESS score to European Quality of Life-5 Dimensions three-level version for device cost–utility. Using SP2 as the standard device, MADs produced higher mean costs and mean QALYs than CM [incremental cost-effectiveness ratio (ICER) £6687/QALY]. From a willingness to pay (WTP) of £15,367/QALY, CPAP is cost-effective, although the likelihood of MADs (p = 0.48) and CPAP (p = 0.49) being cost-effective is very similar. Both were better than CM, but there was much uncertainty in the choice between CPAP and MAD (at a WTP £20,000/QALY, the probability of being the most cost-effective was 47% for MAD and 52% for CPAP). When SP2 lifespan increased to 18 months, the ICER for CPAP compared with MAD became £44,066. The ICER for SP1 compared with CM was £1552, and for bMAD compared with CM the ICER was £13,836. The ICER for CPAP compared with SP1 was £89,182, but CPAP produced lower mean costs and higher mean QALYs than bMAD. Differential compliance rates for CPAP reduces cost-effectiveness so MADs become less costly and more clinically effective with CPAP compliance 90% of SP2.Conclusions: Mandibular advancement devices are clinically effective and cost-effective in mild to moderate OSAH. A semi-bespoke MAD is the appropriate first choice in most patients in the short term. Future work should explore whether or not adjustable MADs give additional clinical and cost benefits. Further data on longer-term cardiovascular risk and its risk factors would reduce uncertainty in the health economic model and improve precision of effectiveness estimates. © Queen’s Printer and Controller of HMSO 2014.


PubMed | Maxillofacial Unit, Imperial College London, Brunel University, Medical Research Council Biostatistics Unit and 2 more.
Type: Journal Article | Journal: Health technology assessment (Winchester, England) | Year: 2014

Obstructive sleep apnoea-hypopnoea (OSAH) causes excessive daytime sleepiness (EDS), impairs quality of life (QoL) and increases cardiovascular disease and road traffic accident risks. Continuous positive airway pressure (CPAP) treatment is clinically effective but undermined by intolerance, and its cost-effectiveness is borderline in milder cases. Mandibular advancement devices (MADs) are another option, but evidence is lacking regarding their clinical effectiveness and cost-effectiveness in milder disease.(1) Conduct a randomised controlled trial (RCT) examining the clinical effectiveness and cost-effectiveness of MADs against no treatment in mild to moderate OSAH. (2) Update systematic reviews and an existing health economic decision model with data from the Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea-hypopnoea (TOMADO) and newly published results to better inform long-term clinical effectiveness and cost-effectiveness of MADs and CPAP in mild to moderate OSAH.A crossover RCT comparing clinical effectiveness and cost-effectiveness of three MADs: self-moulded [SleepPro 1 (SP1); Meditas Ltd, Winchester, UK]; semibespoke [SleepPro 2 (SP2); Meditas Ltd, Winchester, UK]; and fully bespoke [bespoke MAD (bMAD); NHS Oral-Maxillofacial Laboratory, Addenbrookes Hospital, Cambridge, UK] against no treatment, in 90 adults with mild to moderate OSAH. All devices improved primary outcome [apnoea-hypopnoea index (AHI)] compared with no treatment: relative risk 0.74 [95% confidence interval (CI) 0.62 to 0.89] for SP1; relative risk 0.67 (95% CI 0.59 to 0.76) for SP2; and relative risk 0.64 (95% CI 0.55 to 0.76) for bMAD (p<0.001). Differences between MADs were not significant. Sleepiness [as measured by the Epworth Sleepiness Scale (ESS)] was scored 1.51 [95% CI 0.73 to 2.29 (SP1)] to 2.37 [95% CI 1.53 to 3.22 (bMAD)] lower than no treatment (p<0.001), with SP2 and bMAD significantly better than SP1. All MADs improved disease-specific QoL. Compliance was lower for SP1, which was unpopular at trial exit. At 4 weeks, all devices were cost-effective at 20,000/quality-adjusted life-year (QALY), with SP2 the best value below 39,800/QALY.A MEDLINE, EMBASE and Science Citation Index search updating two existing systematic reviews (one from November 2006 and the other from June 2008) to August 2013 identified 77 RCTs in adult OSAH patients comparing MAD with conservative management (CM), MADs with CPAP or CPAP with CM. MADs and CPAP significantly improved AHI [MAD -9.3/hour (p<0.001); CPAP -25.4/hour (p<0.001)]. Effect difference between CPAP and MADs was 7.0/hour (p<0.001), favouring CPAP. No trials compared CPAP with MADs in mild OSAH. MAD and CPAP reduced the ESS score similarly [MAD 1.6 (p<0.001); CPAP 1.6 (p<0.001)].An existing model assessed lifetime cost-utility of MAD and CPAP in mild to moderate OSAH, using the revised meta-analysis to update input values. The TOMADO provided utility estimates, mapping ESS score to European Quality of Life-5 Dimensions three-level version for device cost-utility. Using SP2 as the standard device, MADs produced higher mean costs and mean QALYs than CM [incremental cost-effectiveness ratio (ICER) 6687/QALY]. From a willingness to pay (WTP) of 15,367/QALY, CPAP is cost-effective, although the likelihood of MADs (p=0.48) and CPAP (p=0.49) being cost-effective is very similar. Both were better than CM, but there was much uncertainty in the choice between CPAP and MAD (at a WTP 20,000/QALY, the probability of being the most cost-effective was 47% for MAD and 52% for CPAP). When SP2 lifespan increased to 18 months, the ICER for CPAP compared with MAD became 44,066. The ICER for SP1 compared with CM was 1552, and for bMAD compared with CM the ICER was 13,836. The ICER for CPAP compared with SP1 was 89,182, but CPAP produced lower mean costs and higher mean QALYs than bMAD. Differential compliance rates for CPAP reduces cost-effectiveness so MADs become less costly and more clinically effective with CPAP compliance 90% of SP2.Mandibular advancement devices are clinically effective and cost-effective in mild to moderate OSAH. A semi-bespoke MAD is the appropriate first choice in most patients in the short term. Future work should explore whether or not adjustable MADs give additional clinical and cost benefits. Further data on longer-term cardiovascular risk and its risk factors would reduce uncertainty in the health economic model and improve precision of effectiveness estimates.This trial is registered as ISRCTN02309506.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 67. See the NIHR Journals Library website for further project information.


Tatullo M.,Tecnologica Research Institute | Marrelli M.,Maxillofacial Unit | Shakesheff K.M.,University of Nottingham | White L.J.,University of Nottingham
Journal of Tissue Engineering and Regenerative Medicine | Year: 2015

Dental pulp stem cells (DPSCs) are a promising source of cells for numerous and varied regenerative medicine applications. Their natural function in the production of odontoblasts to create reparative dentin support applications in dentistry in the regeneration of tooth structures. However, they are also being investigated for the repair of tissues outside of the tooth. The ease of isolation of DPSCs from discarded or removed teeth offers a promising source of autologous cells, and their similarities with bone marrow stromal cells (BMSCs) suggest applications in musculoskeletal regenerative medicine. DPSCs are derived from the neural crest and, therefore, have a different developmental origin to BMSCs. These differences from BMSCs in origin and phenotype are being exploited in neurological and other applications. This review briefly highlights the source and functions of DPSCs and then focuses on in vivo applications across the breadth of regenerative medicine. © 2014 The Authors.


Johansson L.-A.,Maxillofacial Unit | Isaksson S.,Maxillofacial Unit | Lindh C.,Malmö University | Becktor J.P.,Maxillofacial Unit | Sennerby L.,Gothenburg University
Journal of Oral and Maxillofacial Surgery | Year: 2010

Purpose: The aim of this study was to prospectively evaluate the status of implants, marginal bone loss, and outcome of maxillary sinus floor augmentation in patients undergoing maxillary sinus lift and simultaneous implant placement with the use of bone grafts harvested adjacent to the actual surgical site. Materials and Methods: Patients in need of maxillary sinus floor augmentation to enable implant placement were enrolled in 2 different groups. In group A, a "bone trap" was used to harvest bone debris during implant preparation with additional bone collected by further drilling adjacent to the implant sites. In group B, a "bone scraper" was used to harvest cortical bone chips from the zygomatic buttress and from the lateral sinus wall before opening of a bony window. All patients were provided a fixed partial denture after a healing period of 3 to 6 months. A total of 61 patients with 81 Straumann implants (Institut Straumann AG, Basel, Switzerland) were assessed, with 17 patients (20 implants) in group A and 44 patients (61 implants) in group B. Results: One implant was lost (in group B) before loading. The survival rate after a follow-up of 12 to 60 months was 98.8%. There was no significant difference in marginal bone loss on the mesial and distal sides of the implant when baseline to 1-year registration was compared with baseline to final registration. During the same time, graft height decreased significantly on the distal apical side of the implants. Conclusions: Bone grafts can be locally harvested at the site of the maxillary sinus augmentation procedure to enable placement, successful healing, and loading of 1 to 3 implants. © 2010 American Association of Oral and Maxillofacial Surgeons.


Abrahamsson P.,Maxillofacial Unit | Abrahamsson P.,Malmö University | Walivaara D.-A.,Maxillofacial Unit | Isaksson S.,Maxillofacial Unit | And 2 more authors.
Journal of Oral and Maxillofacial Surgery | Year: 2012

Purpose: To evaluate the outcome of intraoral soft tissue expansion by measuring the profile change using objective 3D metering equipment and to evaluate localized bone grafting after soft tissue expansion with regard to gain of bone and complications. Materials and Methods: Using a prospective study design, we asked patients with an osseous and soft tissue defect on the buccal aspect of the alveolar process to participate in this study. In 10 patients (experimental group) a self-inflatable soft tissue expander was placed under the periosteum. After 2 weeks, the expander was removed and a particulated onlay bone graft was placed in the expanded area, protected by a titanium mesh covered with a collagen membrane. Ten patients (reference group) were treated with a mandibular ramus bone block graft. The soft tissue profile was registered before each surgical procedure. The vertical and lateral dimensions of the bone grafts were noted at the grafting procedure and at the implant installation. P <.05 was considered significant. Results: The mean soft tissue profile change was 2.9 ± 1.1 mm after soft tissue expansion and 2.3 ± 2.1 mm at implant placement in the experimental group compared with 1.5 ± 1.4 mm at implant placement in the reference group (P =.065). Two patients had minor perforations of the soft tissue expander. In the experimental group, the mean lateral bone augmentation after soft tissue expansion was 4.5 ± 1.3 mm, and after healing, it decreased to 3.9 ± 1.4 mm (P =.063). The mean vertical augmentation was 4.1 ± 1.7 mm and had decreased at implant placement to 3.0 ± 1.4 mm (P =.041). In the reference group, the mean lateral augmentation was 3.8 ± 0.8 mm, and after healing, it reduced to 2.7 ± 0.8 mm (P =.024). The mean vertical augmentation was 2.9 ± 0.9 mm, and after healing of the bone graft at implant placement, it was reduced to 1.6 ± 0.8 mm (P =.01). When smokers were excluded, there was significantly less resorption of the bone grafts in both lateral (P =.049) and vertical (P =.012) dimensions in the experimental group compared with the reference group. Conclusion: Hydrogel expansion of the periosteum is an applicable method to achieve a surplus of soft tissue to cover bone grafts. More refinements to the technique may be required to minimize complications, especially in smoking patients. © 2012 American Association of Oral and Maxillofacial Surgeons.

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