For maxillofacial surgeons, the reconstruction of mandibular defects that result from the ablation of tumors or traumatic injury poses a formidable, and somewhat controversial challenge. The maxillofacial region is a complex and prominent region with specialized functions. For a patient to maintain a high quality of life, it is important to maintain functions such as speech, deglutination, mastication, facial expression, and airway maintenance. Furthermore, the cosmetics of this region play an equal or greater role in the perceived quality of life of the patient.

Several devices used to harvest stem/progenitor cells from bone marrow are available to clinicians. This study compared three devices measuring stem cell yields and correlating those yields to bone regeneration. A flexible forward aspirating system Marrow Marxman (MM), a straight needle aspirating on withdrawal system Marrow Cellutions (MC), and a straight needle aspirating on withdrawal and centrifuging the aspirate (BMAC) were compared in a side-to-side patient comparison, as well as tissue engineered bone grafts. The FlexMetric system (MM) produced greater CFU-f values compared to the straight needle (MC) Δ = 1083/ml, p < 0.001 and 1225/ml, p < 0.001 than the BMAC system. This increased stem/progenitor cell yield also translated into a greater radiographic bone density at 6 months Δ = 88.3 Hu, p ≤ 0.001 versus MC and Δ = 116.7, p < 0.001 versus BMAC at 6 months and Δ = 72.2, p < 0.001 and Δ = 93.3, p < 0.001 at 9 months respectively. The increased stem/progenitor cell yield of the MM system clinically translated into greater bone regeneration as measured by bone volume p < 0.014 and p < 0.001 respectively, trabecular thickness p < 0.007 and p < 0.002 respectively, and trabecular separation p = 0.011 and p < 0.001. A flexible bone marrow aspirator produces higher yields of stem/progenitor cells. Higher yields of stem/progenitor cells translate into greater bone regeneration in tissue engineering. Flexmetric technology produces better bone regeneration due to a forward aspiration concept reducing dilution from peripheral blood and its ability to target lining cells along the inner cortex. Centrifugation systems are not required in tissue engineering procedures involving stem/progenitor cells due to nonviability or functional loss from g-forces.

Purpose: The purpose of the present study is to compare the characteristics of dog bite wounds to the face and that of the rest of the body among the pediatric population in the United States and to determine independent risk factors for dog bite wounds to the face. Methods: A retrospective cohort study was conducted using the Kids' Inpatient Database. There were multiple, heterogenous predictor variables. The primary outcome variable was a facial dog bite. A multivariate logistic regression was employed to identify independent risk factors for the primary outcome variable. A P value less than.05 was the threshold for statistical significance. Results: Our final sample consisted of 9,057 patients who suffered dog bite injuries, of which 2,913 (32.2%) occurred on the face. Relative to individuals aged 16-20 years, individuals aged 0-5 (odds ratio [OR] 5.7; confidence interval [CI] 4.0, 8.1), 6-10 (OR 3.8; CI 2.6, 5.5), and 11-15 years (OR 1.6; CI 1.1, 2.5) were all independently associated with increased odds of incurring a facial dog bite injury. Patients who were not admitted electively were 2.5 times (CI 1.4, 4.6) more likely to incur a facial dog bite injury relative to patients who were admitted electively. Conclusions: Young children (0-5 years) were at the greatest risk for facial dog bites relative to children aged 16-20 years. Dog bites that were admitted on emergency weremore likely to occur on the face relative to those that were electively admitted to the hospital. To reduce the risk for facial dog bites and the host of chronic psychological ramifications that accompany them, established preventative strategies ought to be exercised.

BackgroundAdverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drugs or devices with large sales, large financial settlements, and large numbers of injured persons. We report on impacts on patients, clinicians, and manufacturers following very serious ADR reporting.MethodsWe reviewed clinician identified very serious ADRs published between 1997 and 2019. Drugs and devices associated with reports of very serious ADRs were identified. Included drugs or devices had market removal discussed at Food and Drug Advisory (FDA) Advisory Committee meetings, were published by clinicians, had sales > $1 billion, were associated with CTCAE Grade 4 or 5 toxicity effects, and had either >$1 billion in settlements or >1,000 injured patients. Data sources included journals, Congressional transcripts, and news reports. We reviewed data on: 1) timing of ADR reports, Boxed warnings, and product withdrawals, and 2) patient, clinician, and manufacturer impacts. Binomial analysis was used to compare sales pre- and post-FDA Advisory Committee meetings.FindingsTwenty very serious ADRs involved fifteen drugs and one device. Legal settlements totaled $38.4 billion for 753,900 injured persons. Eleven of 18 clinicians (61%) reported harms, including verbal threats from manufacturer (five) and loss of a faculty position (one). Annual sales decreased 94% from $29.1 billion pre-FDA meeting to $4.9 billion afterwards (p<0.0018). Manufacturers of four drugs paid $1.7 billion total in criminal fines for failing to inform the FDA and physicians about very serious ADRs. Following FDA approval, the median time to ADR reporting was 7.5 years (Interquartile range 3,13 years). Twelve drugs received Box warnings and one drug received a warning (median, 7.5 years following ADR reporting (IQR 5,11 years). Six drugs and 1 device were withdrawn from marketing (median, 5 years after ADR reporting (IQR 4,6 years)).InterpretationBecause very serious ADRs impacts are so large, policy makers should consider developing independently funded pharmacovigilance centers of excellence to assist with clinician investigations.FundingThis work received support from the National Cancer Institute (1R01 CA102713 (CLB), https://www.nih.gov/about-nih/what-we-do/nih-almanac/national-cancer-institute-nci; and two Pilot Project grants from the American Cancer Society's Institutional Grant Award to the University of South Carolina (IRG-13–043–01) https://www.cancer.org/ (SH; BS).

Mr. Richard Clarke presents in this Journal his arguments against continued application of hyperbaric oxygen (HBO2) therapy to the pre-extraction neoadjuvant treatment or the treatment of frank mandibular ORN. In the same article he advocates a promising renewed interest in HBO2 as a radiosensitizer. Arguments against HBO2 prior to extractions are based on several papers which consistently include low-risk patients. The just-released HOPON trial reports a negative pre-extraction outcome for HBO2, but patients were enrolled with radiation doses as low as 50Gy. For advanced mandibular necrosis (Marx Stage III) requiring resection, fibular free flap reconstruction is advocated. A high complication rate with free flaps is acknowledged but the magnitude of these complications is not discussed. A cost savings for this procedure is suggested, but no mention is made of the typical cost of the procedure ($90,000) or the requirement of a typical one-week hospital stay, including an initial one or two days in the ICU. Nor is mention made of the very low rate of subsequent dental rehabilitation. The success reported by Delainian, et al. employing pentoxifylline, Vitamin E and sometimes a bisphosphonate is equated to the four decades of HBO2 success with the Marx protocol for Stage I and II ORN. In the phase II trial by Delainian (not randomized) six of her 54 patients died secondary to sepsis, and she graded patients as complete responders if 5mm or less bone was exposed. Even at entry patients had an average of only 1.7 cm exposed bone and treatment was prolonged (16 + or -9 months). Any cost comparison studies will have to account for the indirect expenses of this prolonged treatment including lost productivity.

Do not let the title of this editorial suggest to you that there is a recently discovered link between tooth decay and osteoporosis. There is none. However, both of them teach us a lesson about theoretical medicine and dentistry versus real medicine and dentistry. In 1967, I sat together with my classmates at the now closed Northwestern University Dental School eagerly awaiting our first lecture in operative dentistry. The instructor, a no-nonsense retired Navy dentist, announced in a sad tone that he did not know why we were there. A bewildered class was then told that within 5 years, there would be a vaccine for dental caries and even periodontal disease so that we would have nothing to treat. Despite his warning, we all pressed on through our 4 years, and most all of us now look back on productive careers, which have witnessed too many carious teeth and too much periodontal inflammation. After 51 years, there is no vaccine for either of these dental diseases, and although fluoridation and public awareness have made an impact, dental caries and periodontitis continue to plague mankind. In 1995, alendronate (Fosamax Merck Co) was introduced to cure osteoporosis and prevent postmenopausal women from spine and hip fractures. Heavily marketed and advancing the unfounded fearful prediction that more than 50% of all woman older than 50 years would sustain such fractures in their lifetime and 15% would die as a complication of these fractures, Alendronate and the entire class of bisphosphonates that followed, for example, Risedronate (Actonel [Warner Chilcott, Sanofi-Aventis], Ibandronate [Boniva Roche]) became exceedingly popular and prescribed widely. More recently, denosumab (Prolia Amgen Co) was introduced as an even more effective osteoporotic cure. However, like the vaccines for dental caries and periodontal disease, the class of bisphosphonates and RANKL inhibitors such as denosumab have proven to be ineffective in treating osteoporosis. In the March 2018 issue of Scientific American, Claudia Willis, a nonphysician, nondentist, medical writer, attributed the continuation and even an increase in osteoporosis to the dental profession's publications on ONJ and the orthopedic profession's publications on bisphosphonate-induced femur fractures. She claimed that physicians are discouraged from prescribing these 2 classes of medication because of these publications causing osteoporosis to run wild even though easily treated. However, if she had researched the nonbiased scientific data, she would have found the real reason for physicians to reduce their prescribing these drugs is because their ineffectiveness. How do we know this? We know this by the following: Track record: in dealing with more than 150 ONJ cases in osteopenic and osteoporotic women, 41% had taken 2 or more of these drugs because of a minimal or no response to first or second drugs. The drug companies own studies: Merck's company data on alendronate indicated an equal placebo response to alendronate for the first 18 months. Between 18 and 36 months, the alendronate response was only 9% better than the placebo. After 36 months the response of the placebo and alendronate was again equal. Moreover, an independent study identified only a 3% better response to alendronate in the 18- to 36-month time frame. The literature: although the drug companies have flooded the literature with positive results from their paid consultants, 3 independent studies show the reality of their ineffectiveness. In the first study, the author's found that bisphosphonate treatment of 270 women with osteopenia for 3 years would only prevent 1 fracture. In the second study, the author's concluded that bisphosphonate treatment of 88 women with osteoporosis for 5 years would only prevent 1 fracture. In the third study, discontinuing alendronate after 5 years did not result in fractures compared with those who continued it. The FDA: In September of 2011, the FDA comes out with its official bisphosphonate recommendation after reviewing all the current data. Their conclusions were the following: A. Women on bisphosphonates for osteoporosis must be re-examined after 3 years. There is no documented benefit beyond 3 years of treatment. B. No woman with osteoporosis needs to be on a bisphosphonate for more than 5 years. Dental caries, periodontal disease, and osteoporosis are 3 diseases, each with a unique and complete biology, where genetics and environmental influences play a large role. No vaccine, pill, or injection, no matter how heavily marketed or hyped, has been or is likely to cure either. Today's practitioners in both dentistry and medicine must be alert and skeptical to the promise of theoretical cures. Will the next promise be a cancer cure? A stem cell therapy to cure diabetes? A coated dental implant that will never fail” Or even the regeneration of tooth for implantation so that the dental implant dentist will have nothing to treat just like my dental school class 51 years ago?

Purpose: Reconstruction of the temporomandibular joint defect is challenging. The purposes of this study were to identify factors associated with the accuracy of positioning of a titanium condylar prosthesis and to measure the association between the accuracy of the condylar prosthesis position and postoperative complications. Materials and Methods: We designed a retrospective cohort study and enrolled a sample of patients whose condyle was reconstructed with an alloplastic condylar prosthesis. The primary predictor variable was the accurate positioning of the prosthesis in the fossa in comparison with the native condyle. The primary outcome variable was the development of postoperative complications related to the inaccurate positioning of the condylar prosthesis. Other variables were included and discussed in detail in the article. In addition, the postoperative pain level was assessed with a visual analog scale score. Because of the small sample size, we elected to use a descriptive data analysis for the research. Results: The final sample was composed of 40 patients, with a mean age of 38 years. A postoperative complication developed in 6 patients (15%), including cutaneous plate exposure after radiation therapy, erosion through the tympanic plate of the condylar fossa, and erosion into the temporal bone. The average displacement of the condylar prosthesis in the patients in whom complications developed was 5.04 mm in the vertical and 1.5 mm in the lateral dimension, which was less than the average of all other patients in the study. Seven patients reported higher levels of pain represented by the visual analog scale score, and this was associated with increased deviation of the condylar prosthesis position by 4.4% and 16.6% in the vertical and lateral dimensions, respectively. Conclusions: This retrospective study showed that the amount of displacement of the temporomandibular joint prosthesis did not correlate with the incidence of complications or postoperative pain. (C) 2018 American Association of Oral and Maxillofacial Surgeons

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This unique reference provides a comprehensive guide to pediatric head and neck pathology in patients up to the age of 21. Chapters take a clinicopathologic approach, offering insight into the pathobiology, diagnosis and treatment of both common and rare disorders. Imaging studies and immunohistochemical techniques are discussed alongside accepted and emerging molecular tools. The authors&apos; holistic approach ensures coverage of the surgical management principles that pathologists must understand, particularly when called upon to diagnose odontogenic tumors and cysts, as well as benign and malignant salivary gland neoplasms. The book is richly illustrated in color throughout. Each copy of the printed book is packaged with a password, providing online access to the book&apos;s text and image library. Written by leaders in head and neck pathology and surgery, this is an essential guide to solving the diagnostic dilemmas that pathologists and clinicians encounter in the assessment of pediatric head and neck disease.

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A summary is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.