Temporomandibular joint prosthesis as treatment option for mandibular condyle fractures: a systematic review and meta-analysis.

The aim of this study was to perform a systematic review of the literature on the temporomandibular joint (TMJ) prosthesis as a treatment option after mandibular condyle fracture. Three databases were searched (PubMed, Embase, Cochrane Library) and 2670 unique papers were identified. A total of 337 studies were included (121 case reports, 89 case series, and 127 cohort/clinical studies). In total 14,396 patients and 21,560 prostheses were described. Of the 127 cohort or clinical studies, 100 (79%) reported inclusion criteria, 54 (43%) reported exclusion criteria, and 96 (76%) reported the inclusion period. The base population from which patients were recruited was reported in 57 studies (45%). The reason for TMJ prosthesis implantation was reported for 4177 patients (29.0%). A history of condylar fracture was present in 83 patients (2.0%); a history of mandibular trauma was present in 580 patients (13.9%). The meta-analysis showed a pooled prevalence of condylar fracture of 1.6% (95% confidence interval 0.9-2.4%) and a pooled prevalence of trauma or condylar fracture of 11.3% (95% confidence interval 7.1-16.0%). Heterogeneity was highly significant (P < 0.001). The TMJ prosthesis appears to be reserved for patients with persistent pain, bony or fibrous ankylosis, or osteomyelitis after primary closed or open treatment of fractures of the mandibular condyle.

Biodegradable versus titanium osteosynthesis in maxillofacial traumatology: a systematic review with meta-analysis and trial sequential analysis.

Titanium osteosynthesis is currently the fixation system of choice in maxillofacial traumatology. Biodegradable osteosynthesis systems have the ability to degrade in the human body. The aim of this study was to conduct a systematic review, with meta- and trial sequential analyses, to assess the efficacy and morbidity of biodegradable versus titanium osteosynthesis after maxillofacial trauma. MEDLINE, Embase, and CENTRAL were searched for randomized controlled trials and prospective and retrospective controlled studies. Five time periods were studied: perioperative, short-term (0-4 weeks), intermediate (6-12 weeks), long-term (>12 weeks), and overall follow-up. After screening 3542 records, 24 were included. All had a high risk of performance and detection bias due to the nature of the interventions. Meta-analysis showed no differences in efficacy or morbidity between biodegradable and titanium osteosynthesis. The risk of perioperative screw breakage was significantly higher (risk ratio 17.13, 95% confidence interval 2.19-34.18) and the symptomatic plate removal rate lower in the biodegradable group (risk ratio 0.11, 95% confidence interval 0.02-0.57), which was confirmed by the trial sequential analysis. The quality of evidence ranged from very low to moderate. Based on the narrative review and meta-analyses, current evidence shows that biodegradable osteosynthesis is a viable alternative to titanium osteosynthesis when applied in the treatment of maxillofacial trauma, with similar efficacy but significantly lower symptomatic plate removal rates. Perioperative screw breakage occurred significantly more often in the biodegradable group compared to the titanium group.

Complications of locking and non-locking plate systems in mandibular fractures.

This systematic review and meta-analysis was performed to critically assess the methodological quality of the existing systematic reviews, and to evaluate the postoperative complications of the mandibular fractures treated with locking and non-locking plate systems. An electronic search was conducted in PubMed, Embase, Web of Science, Cochrane library's electronic databases and grey literate using a combination of Medical Subject Heading terms and key words, until September 2018. No restrictions were applied to the search strategy. In total, three relevant systematic reviews were included, and the quality of these studies was low. A total of 33 studies (20 randomized studies and 13 non-randomized studies) were included in this systematic review, and 16 of them were included in meta-analysis. Most of the included randomized studies had an unclear risk of bias (Cochrane Collaboration); the quality of non-randomized studies ranged between 6 and 17 (Methodological Index for Non-Randomized Studies - MINORS). Based on the results of our meta-analysis, we conclude that locking plates are superior only with respect to the need for mandibulomaxillary fixation (MMF) in the early postoperative period.

Open treatment of condylar fractures via extraoral approaches: A review of complications.

BACKGROUND: There is considerable controversy about whether condylar fractures should be treated open or closed. Even when there is a clear indication for open treatment, the appropriate approach opens another debate. PURPOSE: To provide a clear overview on the complications of extraoral approaches to condylar fractures. METHODS: Systematic literature search of all indexed years on PubMed, Medline, and Embase. For detailed analysis, we selected 70 studies. RESULTS: Of the 2783 patients who were studied with respect to facial nerve function, 338 (12%) experienced some form of weakness. Most (95%) achieved full recovery. In 17 of the 338 patients (5%), these paralyses were permanent. A hematoma occurred in 1.7%, an infection of the wound in ≥2.9%, Frey syndrome in 1.1%, a sialocele in 2.6%, a salivary fistula in ≥4.8%, sensory disturbance of the great auricular nerve in 7.9%, and an unsatisfactory scar in ≥1.6% of the patients. CONCLUSION: Due to the great diversity in fractures, approaches, and surgical techniques, it is difficult to objectively compare surgical techniques for condylar fractures and their complications. Based on the literature studied in this review, we propose a treatment protocol with respect to open treatment approaches.

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.

BACKGROUND: Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation. AIM: The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery. MATERIALS AND METHODS: The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS). RESULTS: After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups. CONCLUSION: In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures. TRIAL REGISTRATION: http://controlled-trials.com ISRCTN44212338.

Closed treatment of unilateral mandibular condyle fractures in adults: a systematic review.

Of all mandibular fractures, 25-35% are condylar. Many studies have focused on whether to treat such fractures via open or closed modalities. A uniform protocol for closed treatment is lacking, but such a protocol could ensure good clinical practice. The aims of this systematic review were to provide an overview of the published studies exclusively pertaining to closed treatment and to summarize the existing modalities for closed treatment and their clinical outcomes. Sixteen studies were selected for detailed analysis. The treatments given were highly variable, ranging from doing nothing to applying maxillomandibular fixation with stainless steel wires. The results of the different studies and the treatment modalities used were difficult to interpret; however no clear differences in the outcome measures were seen between the treatment modalities applied. Complications encountered after closed treatment included malocclusion, limited mouth opening, reduced range of motion, and persistent pain. Due to the heterogeneity between groups, high loss-to-follow-up, poor descriptions of the treatments given, and variability in outcome measurement methods, no clear associations between adverse outcomes and the treatments applied could be determined. This review suggests that due to the high level of methodological variability in the relevant studies published to date, there are currently no uniform standards for the closed treatment of condylar fractures that can be expected to yield good clinical results. The establishment of such standards could potentially improve treatment outcomes.

Controversies in orbital reconstruction-III. Biomaterials for orbital reconstruction: a review with clinical recommendations.

The goal of orbital reconstruction is to repair trauma defects, to correct the position of the eye anatomically, avoiding enophthalmos, and to restore ocular function. For the reconstruction of (trauma) defects, many surgeons recommend materials that can be bent into an anatomical shape and that possess the properties of radiopacity and long-term stability. However, apart from these desired properties, the ideal material for orbital reconstruction remains controversial. Autologous bone is often mentioned as the 'gold standard,' likely because of its mechanical properties, revascularization potential, and its adaptation to the orbital tissue with minimal acute and chronic immune reactivity. However, autologous bone can show unpredictable resorption rates and suboptimal volume correction. In recent years, an increasing interest in the use of alloplasts for orbital reconstruction has become apparent in the literature. Modern technological advantages, such as preoperative planning, navigation, and perioperative imaging, can be beneficial in the decision to choose a certain implant. The aim of this review is to give a comprehensive overview of the advantages and disadvantages of materials used to reconstruct traumatic orbital defects and to provide a practical, evidence-based, complexity-driven set of guidelines.

Cost-Effectiveness of a Biodegradable Compared to a Titanium Fixation System in Maxillofacial Surgery: A Multicenter Randomized Controlled Trial.

BACKGROUND: Biodegradable fixation systems could reduce/delete the problems associated with titanium plate removal. This means less surgical discomfort, and a reduction in costs. AIM: The aim of the present study was to compare the cost-effectiveness between a biodegradable and a titanium system in Maxillofacial surgery. MATERIALS AND METHODS: This multicenter RCT was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO), a Le Fort-I osteotomy, or a bi-maxillary osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin) or to a biodegradable group (Inion CPS). Costs were assessed from a societal perspective. Health outcomes in the incremental cost-effectiveness ratio (ICER) were bone healing (8 weeks) and plate removal (2 years). RESULTS: In 25 out of the 117 patients who were randomized to the biodegradable group, the maxillofacial surgeon made the decision to switch to the titanium system intra-operatively. This resulted in an Intention-To-Treat (ITT-)analysis and a Treatment-Received (TR-) analysis. Both analyses indicated that operations performed with titanium plates and screws had better health outcomes. In the TR-analysis the costs were lower in the biodegradable group, in the ITT-analysis costs were lower in the titanium group. CONCLUSION AND DISCUSSION: The difference in costs between the ITT and the TR analyses can be explained by the intra-operative switches: In the TR-analysis the switches were analysed in the titanium group. In the ITT-analysis they were analysed in the biodegradable group. Considering the cost-effectiveness the titanium system is preferable to the biodegradable system in the regular treatment spectrum of mandibular, Le Fort-I, and zygomatic fractures, and BSSO's, Le Fort-I osteotomies and bimaxillary osteotomies. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN 44212338.

Recovery of mouth-opening after closed treatment of a fracture of the mandibular condyle: a longitudinal study.

The aim of this retrospective study was to assess recovery of mouth opening after closed treatment of fractures of the mandibular condyle, and analyse which characteristics might influence recovery. We measured mouth opening in 142 patients (mean (SD) age 30 (14) years, 96 of whom were male) during follow-up at 3, 6, 13, 26, and 52 weeks after the injury. Fractures were assessed on radiographs. Data were analysed using a multilevel analysis. Half the fractures were of the low condylar neck (n=71). Thirty-seven patients had bilateral condylar fractures, 29 had dislocated fractures, and in 80 the fracture was displaced. One or more additional mandibular fractures were present in 68. During follow-up mean (SD) mouth opening increased to: 33.6 (9.6) at 3 weeks, 40.1 (10.0) at 6 weeks, 45.1 (9.6) at 13 weeks, 49.8 (9.5) at 26 weeks, and 52.6 (7.5) at 52 weeks. Older age, female sex, displaced fracture, bilateral fractures, additional mandibular fractures, and the interaction between follow-up time and additional mandibular fractures, were predictors of a less favourable recovery of mouth opening. Clinicians can use the results of this study to predict recovery of mouth opening after closed treatment of fractures of the mandibular condyle at first consultation.

Comparison of the long-term skeletal stability between a biodegradable and a titanium fixation system following BSSO advancement - a cohort study based on a multicenter randomised controlled trial.

Biodegradable fixation systems could reduce or eliminate the problems associated with removal of titanium plates. A multicenter randomised controlled trial (RCT) was performed in the Netherlands from December 2006-July 2009, and originally 230 injured and orthognathic patients were included. The patients were randomly assigned to either a titanium control group (KLS Martin) or to a biodegradable test group (Inion CPS). The aim of the present study was to compare the long-term skeletal stability of advancement bilateral sagittal split osteotomies (BSSO) of a biodegradable system and a titanium system. Only patients from the original RCT who were at least 18 years old and who had a BSSO advancement osteotomy were included. Those who had simultaneous Le Fort I osteotomy or genioplasty were excluded. Analysis of skeletal stability was made by digital tracing of lateral cephalograms. Long-term skeletal stability in BSSO advancement did not differ significantly between patients treated with biodegradable plates and screws and those treated with titanium plates and screws. Given the comparable amount of relapse, the general use of Inion CPS in the treatment of BSSO advancement should not be discouraged. On the basis of other properties a total picture of the clinical use can be obtained; the short-term stability, the intraoperative switches, the number of plates removed and cost-effectiveness. Trial registration of original RCT: http://www.controlled-trials.com; ISRCTN 44212338.

Poly(trimethylene carbonate) and biphasic calcium phosphate composites for orbital floor reconstruction: a feasibility study in sheep.

In the treatment of orbital floor fractures, bone is ideally regenerated. The materials currently used for orbital floor reconstruction do not lead to the regeneration of bone. Our objective was to render polymeric materials based on poly(trimethylene carbonate) (PTMC) osteoinductive, and to evaluate their suitability for use in orbital floor reconstruction. For this purpose, osteoinductive biphasic calcium phosphate (BCP) particles were introduced into a polymeric PTMC matrix. Composite sheets containing 50 wt% BCP particles were prepared. Also laminates with poly(D,L-lactide) (PDLLA) were prepared by compression moulding PDLLA films onto the composite sheets. After sterilisation by gamma irradiation, the sheets were used to reconstruct surgically-created orbital floor defects in sheep. The bone inducing potential of the different implants was assessed upon intramuscular implantation. The performance of the implants in orbital floor reconstruction was assessed by cone beam computed tomography (CBCT). Histological evaluation revealed that in the orbital and intramuscular implantations of BCP containing specimens, bone formation could be seen after 3 and 9 months. Analysis of the CBCT scans showed that the composite PTMC sheets and the laminated composite sheets performed well in orbital floor reconstruction. It is concluded that PTMC/BCP composites and PTMC/BCP composites laminated with PDLLA have osteoinductive properties and seem suitable for use in orbital floor reconstruction.

Decision-making considerations in application of biodegradable fixation systems in maxillofacial surgery--a retrospective cohort study.

In a recent RCT comparing biodegradable (Inion CPS) with titanium (KLS Martin) plates and screws for fixation of osteotomies or fractures, we found that in 21% of the cases the surgeon decided intra-operatively to switch from biodegradable to titanium. The aim of the current retrospective cohort study was to analyse the reasons for these switches in order to find predictor variables that may be helpful in the decision to use biodegradable devices or not. The surgeons' opinion about the biodegradable system, and if there was a learning curve in the application of the biodegradable system were also investigated. All variables were assessed during the original RCT by using a questionnaire that was completed by the OMF surgeon directly post-operatively. For the outcome variable "surgeons' opinion" a separate questionnaire was used. Regarding the predictor variables a mandibular fracture had a higher risk of switching compared to a BSSO. However, looking at the reasons for these switches no firm conclusions can be drawn. There was a subjective learning curve to acquire the application-skills for the biodegradable system. There were no changes in isolated Le-Fort-I osteotomies despite the fact that the biodegradable system seems more difficult to apply in the midface. Inadequate stability was the main reason for switching. This can be material-related, or related to inexperience with or lack of confidence in the system, or impatience of the surgeon. A learning curve and personal preferences probably play an important role in the decision to switch. We think that with more patience and more experience it should be possible to increase both user comfort and confidence in the biodegradable system of Inion CPS, which likely will decrease the number of intra-operative switches.

Comparison of biodegradable and titanium fixation systems in maxillofacial surgery: a two-year multi-center randomized controlled trial.

Biodegradable osteosynthesis could reduce/delete the problems associated with titanium plate removal. The aim of the present study was to compare the clinical performance in the first 2 post-operative years between a biodegradable and a titanium system in oral and maxillofacial surgery. The multicenter randomized controlled trial (RCT) was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin) or to a biodegradable group (Inion CPS). Plate removal was necessary in 16 of the 134 patients (11.9%) treated with titanium and in 21 of the 87 patients (24.1%) treated with the biodegradable system within the first 2 post-operative years [p = .016, HR biodegradable (95% CI) = 2.2 (1.1-4.2), HR titanium = 1]. Occlusion, VAS, and MFIQ scores showed that both groups had good mandibular function and were (almost) free of pain 1 and 2 years post-operatively (http://controlled-trials.com ISRCTN 44212338).

[Modified polyurethane foam as a local hemostatic agent after dental extractions]. / Gemodificeerd polyurethaanschuim als lokaal hemostaticumn na gebitsextracties.

In this split mouth experiment, the feasibility ofpolyurethane foam as a local hemostatic agent after dental extractions was studied. Ten healthy patients underwent 2 extractions ofa dental element in 1 treatment session. The 10 patients were subsequently randomly divided in a gelatin group and a collagen group. In the gelatin group, a polyurethane foam (PU) was applied in 1 extraction socket, while in the other socket a commercially available gelatin foam was applied. In the collagen group, a PU was applied in 1 socket, and a collagen wadding in the other. All hemostats were removed after 2 minutes, after which the degree of coagulation was measured using a thrombin/antithrombin test and a fibrinogen test. This study suggests that polyurethane foam has hemostatic capacity. Large scale clinical research is needed to confirm this finding, and should indicate whether this hemostatic capacity is clinically relevant.

In vivo behaviour of a biodegradable poly(trimethylene carbonate) barrier membrane: a histological study in rats.

The aim of the present study was to evaluate the response of surrounding tissues to newly developed poly(trimethylene carbonate) (PTMC) membranes. Furthermore, the tissue formation beneath and the space maintaining properties of the PTMC membrane were evaluated. Results were compared with a collagen membrane (Geistlich BioGide), which served as control. Single-sided standardized 5.0 mm circular bicortical defects were created in the mandibular angle of rats. Defects were covered with either the PTMC membrane or a collagen membrane. After 2, 4 and 12 weeks rats were sacrificed and histology was performed. The PTMC membranes induced a mild tissue reaction corresponding to a normal foreign body reaction. The PTMC membranes showed minimal cellular capsule formation and showed signs of a surface erosion process. Bone tissue formed beneath the PTMC membranes comparable to that beneath the collagen membranes. The space maintaining properties of the PTMC membranes were superior to those of the collagen membrane. Newly developed PTMC membranes can be used with success as barrier membranes in critical size rat mandibular defects.

A randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery.

Biodegradable fixation systems could reduce or delete the problems associated with metallic systems, since removal is not necessary. The aim of this study was to establish the effectiveness and safety of biodegradable plates and screws as potential alternatives to metallic ones. This multi-center randomized controlled trial was conducted from December 2006 to July 2009. Included were patients who underwent mandibular and/or Le Fort I osteotomies and those with fractures of the mandible, maxilla, and zygoma. The patients were assigned to a titanium control group (KLS Martin) or to a biodegradable test group (Inion CPS). The primary outcome measure was 'bone healing 8 weeks post-operatively'. The Intention-To-Treat (ITT) analysis of 113 patients in the titanium group and 117 patients in the biodegradable group yielded a significant difference (p < 0.001), primarily because in 25 patients (21%) who were randomized to the biodegradable group, the surgeon made the decision to switch to titanium intra-operatively. Despite this 'inferior' primary outcome result, biodegradable plates and screws could be safely used when it was possible to apply them. The benefits of using biodegradable systems (fewer plate removal operations) should be confirmed during a follow-up of minimally 5 years (Controlled-trials.com ISRCTN number 44212338).

Guided bone regeneration in rat mandibular defects using resorbable poly(trimethylene carbonate) barrier membranes.

The present study evaluates a new synthetic degradable barrier membrane based on poly(trimethylene carbonate) (PTMC) for use in guided bone regeneration. A collagen membrane and an expanded polytetrafluoroethylene (e-PTFE) membrane served as reference materials. In 192 male Sprague-Dawley rats, a standardized 5.0mm circular defect was created in the left mandibular angle. New bone formation was demonstrated by post mortem micro-radiography, micro-computed tomography imaging and histological analysis. Four groups (control, PTMC, collagen, e-PTFE) were evaluated at three time intervals (2, 4 and 12 weeks). In the membrane groups the defects were covered; in the control group the defects were left uncovered. Data were analysed using a multiple regression model. In contrast to uncovered mandibular defects, substantial bone healing was observed in defects covered with a barrier membrane. In the latter case, the formation of bone was progressive over 12 weeks. No statistically significant differences between the amount of new bone formed under the PTMC membranes and the amount of bone formed under the collagen and e-PTFE membranes were observed. Therefore, it can be concluded that PTMC membranes are well suited for use in guided bone regeneration.

Facial clefts and associated limb anomalies: description of three cases and a review of the literature.

Facial clefts are rare congenital malformations. In the literature these are sometimes reported in combination with limb malformations, especially ring constrictions. This article describes three children with facial clefts and limb ring constrictions with various expressions. The first case has a lateral cleft with associated limb malformations. This combination has, to our knowledge, not yet been reported. The literature about facial clefting and the amniotic band syndrome and the possible etiology of clefting and constrictions in these cases are discussed.