Reporting Criteria for Clinical Trials on Medication-Related Osteonecrosis of the Jaw (MRONJ): A Review and Recommendations.

Medication-related osteonecrosis of the jaw (MRONJ) is a complication caused by anti-resorptive agents and anti-angiogenesis drugs. Since we wanted to write a protocol for a randomized clinical trial (RCT), we reviewed the literature for the essential information needed to estimate the size of the active patient population and measure the effects of therapeutics. At the same time, we designed a questionnaire intended for clinicians to collect detailed information about their practices. Twelve essential criteria and seven additional items were identified and compiled from 43 selected articles. Some of these criteria were incorporated in the questionnaire coupled with data on clinical practices. Our review found extensive missing data and a lack of consensus. For example, the success rate often combined MRONJ stages, diseases, and drug treatments. The occurrence date and evaluation methods were not harmonized or quantitative enough. The primary and secondary endpoints, failure definition, and date coupled to bone measurements were not well established. This information is critical for writing a RCT protocol. With this review article, we aim to encourage authors to contribute all their findings in the field to bridge the current knowledge gap and provide a stronger database for the coming years.

Human amniotic membrane application in oral surgery-An ex vivo pilot study.

Objectives: The purpose of this pilot porcine study was to explore and illustrate the surgical application of human amniotic membrane (hAM) in an ex vivo model of medication-related osteonecrosis of the jaw (MRONJ). Material and methods: Five oral and maxillofacial surgeons participated to this study. MRONJ was simulated on porcine mandible specimens. hAM was applied using four different techniques: implantation with complete coverage, implantation with partial coverage, apposition and covering graft material. At the same time, the surgeons evaluated how well the hAM handled and its physical properties during the surgery. Results: Surgeons found that hAM had suitable mechanical properties, as it was easy to detach from the support, handle, bind to the defect and bury. hAM was also found to be strong and stable. The "implantation with complete coverage" and "implantation with partial coverage" techniques were the preferred choices for the MRONJ indication. Conclusion: This study shows that hAM is a graft material with suitable properties for oral surgery. It is preferable to use it buried under the gingiva with sutures above it, which increases its stability. This technical note aims to educate surgeons and provide them with details about the handling of hAM in oral surgery. Clinical relevance: Two surgical techniques for hAM application in MRONJ were identified and illustrated. hAM handling and physical properties during surgery were reported.

Does Penicillin Allergy Increase the Risk of Surgical Site Infection after Orthognathic Surgery? A Multivariate Analysis.

This study aimed to demonstrate an association between the occurrence of surgical site infection (SSI) after orthognathic surgery and penicillin allergy and to assess whether other factors could be associated with the occurrence of SSI. A 10-year monocentric retrospective study was conducted to identify possible risk factors for SSI in orthognathic surgery. Bivariate analyses were performed using Fisher, Student, or Wilcoxon tests and multivariate analyses using logistic regression. Two hundred and sixty-six patients were included, and 3.5% had SSI. Bivariate analyses revealed a significant association between SSI and age at surgery (p = 0.01), penicillin allergy (p = 0.02), and postoperative antibiotic therapy by Clindamycin (Dalacine®) (p = 0.02). Multivariate analyses confirmed the association between the occurrence of SSI and treatment with Clindamycin (Dalacine®) or Clindamycin (Dalacine®) and Metronidazole (Flagyl®) postoperatively (p = 0.04). Antibiotic therapy with Clindamycin (Dalacine®) seems to be associated with a higher rate of SSI, and the mandible was the only site affected by SSI.

Tips and Tricks and Clinical Outcome of Cryopreserved Human Amniotic Membrane Application for the Management of Medication-Related Osteonecrosis of the Jaw (MRONJ): A Pilot Study.

Medication-related osteonecrosis of the jaw (MRONJ) is a complication of certain pharmacological treatments such as bisphosphonates, denosumab, and angiogenesis inhibitors. There are currently no guidelines on its management, particularly in advanced stages. The human amniotic membrane (hAM) has low immunogenicity and exerts anti-inflammatory, antifibrotic, antimicrobial, antiviral, and analgesic effects. It is a source of stem cells and growth factors promoting tissue regeneration. hAM acts as an anatomical barrier with suitable mechanical properties (permeability, stability, elasticity, flexibility, and resorbability) to prevent the proliferation of fibrous tissue and promote early neovascularization at the surgical site. In oral surgery, hAM stimulates healing and facilitates the proliferation and differentiation of epithelial cells in the oral mucosa and therefore its regeneration. We proposed using cryopreserved hAM to eight patients suffering from cancer (11 lesions) with stage 2-3 MRONJ on a compassionate use basis. A collagen sponge was added in some cases to facilitate hAM grafting. One or three hAMs were applied and one patient had a reapplication. Three patients had complete closure of the surgical site with proper epithelialization at 2 weeks, and two of them maintained it until the last follow-up. At 1 week after surgery, three patients had partial wound dehiscence with partial healing 3 months later and two patients had complete wound dehiscence. hAM reapplication led to complete healing. All patients remained asymptomatic with excellent immediate significant pain relief, no infections, and a truly positive impact on the patients' quality of life. No adverse events occurred. At 6 months of follow-up, 80% of lesions had complete or partial wound healing (30 and 50%, respectively), while 62.5% of patients were in stage 3. Radiological evaluations found that 85.7% of patients had stable bone lesions (n = 5) or new bone formation (n = 1). One patient had a worsening MRONJ but remained asymptomatic. One patient did not attend his follow-up radiological examination. For the first time, this prospective pilot study extensively illustrates both the handling and surgical application of hAM in MRONJ, its possible association with a collagen sponge scaffold, its outcome at the site, the application of multiple hAM patches at the same time, and its reapplication.

Impact of intraoperative cone beam computed tomography in the management of zygomatic fractures.

AIM: To evaluate the impact of intraoperative cone beam computed tomography (CBCT) assessment for the surgical management of zygomatic bone fracture (ZF). METHODS: A prospective study was conducted on patients operated on for unilateral ZF during a two-year period. Repositioning of the fractured zygoma was assessed intraoperatively by measuring the position of malar eminences in three dimensions on CBCT. A difference of more than 2 mm between both sides was considered significant and the reduction was judged inadequate. Surgical procedure was adapted to intraoperative imaging findings. RESULTS: The surgical procedures of 47 patients treated for ZF were analyzed. In 15% of the cases (7 patients), the intraoperative CBCT showed an inadequate reduction while the morphological results seemed correct. Those patients benefited from an immediate correction of the reduction. From these 7 patients, reduction was optimized further without the need of osteosynthesis in one case, additional osteosynthesis was performed in 4 cases and 2 patients required both reduction and osteosynthesis revision. CONCLUSION: Intraoperative CBCT control helps to achieve anatomic repositioning in case of ZF. It may reduce the risk of under-treatment and possible reoperation, and of over-treatment meaning systematic ORIF in all fractures.

A scanographic study of asymmetry of the frontal process of zygoma in unilateral coronal synostosis.

INTRODUCTION: Unilateral coronal synostosis (UCS) is a complex craniosynostosis, combining malformations of the upper (frontal bone, orbito-naso-frontal bandeau (ONFB) ) and the middle thirds of the face. In our centre, the surgical correction consists in the repositioning of the ONFB in front of the zygomaticofrontal suture on the affected side. Defects in the corrections have been observed post-operatively for some patients with a persistent asymmetry in the side walls of the orbits. The purposes of our study were to perform an analysis of the frontal process of zygoma (FPZ) in children affected by UCS using preoperative CT-scans and to consider the modification of surgical techniques in order to achieve a better ONFB repositioning and thus, better symmetry. MATERIAL AND METHOD: The preoperative CT-scans of 13 children with UCS who underwent corrective surgery in our department from 2005 to 2016, were analyzed. After the selection of 6 morphological points in 2 and 3 dimensions using planning software, the sutures constituting the coronal arch and the sagittal distances between the coronal plane and the zygomaticofrontal sutures were analyzed. We compared the measurements on the pathological side to the healthy side, the non-affected side being the reference side. The patients included were those for whom the lack of symmetry between the healthy side and the affected side was more than 2 mm. Statistical analyses were carried out using a Student t-test. RESULTS: Of the 13 children, 10 (1 day to 42 months old) met the inclusion criteria. The mean sagittal distance between the coronal plane and the healthy zygomaticofrontal suture was 33.8 mm ± 5.43 mm [range: 25.9: 40.9] [median: 34.3]. On the pathological side, the distance was 28.75 mm ± 4.76 mm [range: 20.8: 36.3] [median: 29.55], (p = 0.04). DISCUSSION: There is a significant asymmetry between the FPZ on the healthy and the pathological sides in children affected by UCS. This asymmetry is variable, therefore justifying a personalized surgical correction whichtakes into account not only the shape of the ONFB but also the degree of asymmetry of the FPZ. A prospective study with immediate preoperative CBCT image acquisition and long-term clinical and radiological follow-up, will be our next step.

Surgical guide for the remodelling of the orbito-naso-frontal bandeau in craniosynostosis surgery.

INTRODUCTION: Craniosynostoses affecting the forehead sutures can not only cause brain damage, but can also have an esthetic impact, because of the associated orbito-naso-frontal deformations. Reshaping the orbito-naso-frontal bandeau (ONFB) is difficult to appreciate perioperatively and should ideally be customized to each child. The aim of this study was to develop a template to guide the surgeon preoperatively towards an ideal customized remodelling of the ONFB. MATERIALS AND METHODS: A previous study conducted on computed tomography scans obtained from healthy children allowed us to conclude that the whole ONFB shape could be accurately described just by the distance measured between the fronto-zygomatic sutures (FZD), independently of age and gender. Our customizable template relies on this measurement. RESULTS: A re-usable template, built around three supports adjustable to a wide range of FZD, was designed using the CAD 3D Rhinoceros® software and machined in stainless steel 316L. The prototype was used for three children with good preliminary results. DISCUSSION AND CONCLUSION: The use of a customizable surgical template allows the surgeon to perform accurate and ideal perioperative remodeling of the ONFB in children suffering from craniosynostosis affecting the forehead sutures. Our prototype is currently the only one to be adjustable according to the FZD. The utility of this device will be assessed in a future prospective clinical study.