Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.
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.
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).
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.
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.
http://controlled-trials.com ISRCTN44212338.
Biodegradable fixation systems could reduce/delete the problems associated with titanium plate removal. This means less surgical discomfort, and a reduction in costs.
The aim of the present study was ...to compare the cost-effectiveness between a biodegradable and a titanium system in Maxillofacial surgery.
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).
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.
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.
Controlled-Trials.com ISRCTN 44212338.
Objectives
The primary aim of the present study was to evaluate the effectiveness of postoperative irrigation of the socket with drinking tap water on inflammatory complications following lower third ...molar removal.
Material and methods
A multicenter randomized controlled trial was carried out from June 2013 to June 2014. In one arm of the study, patients were instructed to irrigate the tooth socket and surgical site with a Monoject® Curved 412 Tip Syringe (Tyco/healthcare-Kendall, Mansfield, MA, USA) with tap water. In a second arm of the study, the standard postoperative instructions did not include irrigation instructions. The incidences of alveolar osteitis and wound infection were recorded for each group and analyzed by the Fisher’s exact test.
Results
A total of 280 patients with 333 mandibular third molars were analyzed. According to the intention-to-treat (ITT) analysis, inflammatory complications occurred in 18 cases in the Monoject® group (11.4 %) compared to 34 cases (19.1 %) in the control group (
p
= 0.04). These complications were associated with significant worse outcomes regarding quality of life, pain, and trismus and caused significantly more missed days of work or study. Female gender, age >26, bone removal, deep impacted third molars, less experienced surgeons, and a high amount of debris at the surgical site were also identified as risk factors for developing inflammatory complications following lower third molar removal.
Conclusion
Irrigation of the surgical site with drinking tap water using a curved syringe following removal of third molars is effective in reducing the risk of inflammatory complications.
Clinical relevance
Water is a very accessible, cost-effective irrigant without side effects and the results from this study have proven that it can be used to reduce the risk of inflammatory complications and associated morbidity following lower third molar removal.
Abstract Purpose The aims of this study were to investigate the effectiveness of cone beam computed tomography (CBCT) compared to panoramic radiography (PR), prior to mandibular third molar removal, ...in reducing patient morbidity, and to identify risk factors associated with inferior alveolar nerve (IAN) injury. Material and methods This multicentre, randomised, controlled trial was performed at three centres in the Netherlands. Adults with an increased risk for IAN injury, as diagnosed from PR, were included in the study. In one arm of the study, patients underwent an additional CBCT prior to third molar surgery. In a second arm of the study, no additional radiographs were acquired. The primary outcome measure was the number of patient-reported altered sensations 1 week after surgery. As secondary outcome measures, the number of patients with objective IAN injury, with long-term (>6 months) IAN injury, the occurrence of other postoperative complications, the Oral Health Related Quality of Life–14 (OHIP-14) questionnaire responses, postoperative pain (visual analogue scale score), duration of surgery, number of emergency visits, and number of missed days of work or study were scored. Results A total of 268 patients with 320 mandibular third molars were analysed according to the intention-to-treat principle. The overall incidence of IAN injury 1 week after surgery was 6.3%. No significant differences between CBCT and PR for temporary IAN injury ( p = 0.64) and all other secondary outcomes were registered. A lingual position of the mandibular canal (MC) and narrowing, in which the diameter of the MC lumen was decreased at the contact area between the MC and the roots, were significant risk factors for temporary IAN injury. Conclusion Although CBCT is a valuable diagnostic adjunct for identification of an increased risk for IAN injury, the use of CBCT does not translate into a reduction of IAN injury and other postoperative complications, after removal of the complete mandibular third molar. In these selected cases of a high risk for IAN injury, an alternative strategy, such as monitoring or a coronectomy, might be more appropriate. ( http://clinicaltrials.gov , NCT02071030 ).
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).
Summary
Background
Localized scleroderma (LoS) is characterized by a phase of disease activity followed by remission. However, disease recurrences occur. Knowledge concerning these recurrences can ...help prompt treatment, thereby preventing disease damage.
Objectives
To investigate the frequency and characteristics of disease recurrences in paediatric‐ and adult‐onset LoS, and to identify patient variables that are associated with a higher risk of disease recurrence.
Methods
Retrospective chart reviews were performed of patients with LoS. Data concerning the frequency and characteristics of the disease recurrences were collected. A multivariate analysis was performed to identify patient variables that were associated with a higher risk of disease recurrence.
Results
In total, 344 patients were included in the analysis, of whom 119 (35%) had paediatric‐onset LoS and 225 (65%) had adult‐onset LoS. Disease recurrence was present in 27% (n = 32) of the paediatric‐onset group and 17% (n = 39) of the adult‐onset group (P = 0·037). Multivariate analysis identified a statistically significant association between disease recurrence and the linear LoS of the limbs subtype, independent of age at disease onset.
Conclusions
Recurrences in LoS occurred in almost one‐quarter of the patients and were most frequent in the linear LoS of the limbs subtype, independent of age at disease onset. These disease recurrences can occur even after many years of quiescent disease. Awareness of the high recurrence rates may help treating physicians to recognize reactivation of the disease, leading to a decreased delay in treatment reinitiation.
What's already known about this topic?
Localized scleroderma is characterized by a phase of disease activity followed by remission. However, disease recurrences occur.
What does this study add?
Recurrences occur in almost one‐quarter of patients and are more frequent in the linear localized scleroderma of the limbs subtype, independent of age at disease onset.
Awareness of high recurrence rates may help treating physicians to recognize reactivation of the disease, leading to a decreased delay in treatment reinitiation.
Abstract 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.
Abstract 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.
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
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