Delayed Infection of Porous Polyethylene Implants After Oncologic Maxillectomy and Reconstruction: 2 Case Reports and Review of Literature.

Medpor porous polyethylene implants are commonly used for facial skeletal reconstruction due to reported biocompatibility, fibrovascularization, and durability. While uncommon, late implant infections are an important consideration. We report delayed infections in 2 patients after unilateral total oncologic maxillectomy and reconstruction using Medpor implants for an ossifying fibroma and squamous cell carcinoma, respectively. In the first patient, annual interval computed tomography (CT) scans showed no recurrence of tumor or inflammatory changes. The second was lost to follow-up after adjuvant chemoradiation 1 year after resection. Patients both presented with swelling, drainage, and erythema around the implant at a mean of 4.5 years following maxillectomy. Both failed several attempts at conservative treatment. Cultures of implants removed at a mean of 2.5 months after infection grew α-hemolytic Streptococcus in the first and multiple organisms in the second, showing that the potential for delayed infection should be considered years after reconstruction.

Evaluation of salivary cortisol levels in relation to dento-maxillary prosthesis adjustment.

PURPOSE: The purpose of this study was to investigate the influence of dento-maxillary prosthesis adjustment procedure on levels of salivary cortisol. METHODS: Nine participants (six men, three women, mean age 65.9 years) took part in this study. Saliva samples were collected before and after dento-maxillary prosthesis adjustment during the four different visits. Free cortisol levels were determined using a salivary cortisol immunoassay kit (expanded-range high-sensitivity salivary cortisol enzyme immunoassay kit, Salimetrics). Besides, original self-report sheets, a 35-item food intake questionnaire, the University of Washington Quality of Life (UW-QOL) questionnaire version 4, and the Geriatric Oral Health Assessment Index (GOHAI) questionnaire were also administered. The changes of salivary cortisol levels were analyzed using 2-level multilevel linear regression, with adjustment for age, sex, and time. Wilcoxon signed-rank test was used to compare scores of the food intake questionnaire, UW-QOL questionnaire, and GOHAI questionnaire. RESULTS: Salivary cortisol levels decreased significantly after carrying out the dento-maxillary prosthesis adjustment procedure. During the third adjustment, the salivary cortisol levels were significantly low. In addition, salivary cortisol levels of participants aged 70 years and over were significantly higher than other aged groups. The total scores for grade III-V of the food intake questionnaire increased significantly. Other questionnaires had a trend toward increasing scores, yet the differences were not significant. CONCLUSIONS: Within the limitations of this study, the results suggest that a reduction in symptoms of discomfort may have an influence on the decrease of salivary cortisol levels in dento-maxillary prosthesis wearers.

Adverse Events in Facial Implant Surgery and Associated Malpractice Litigation.

IMPORTANCE: Facial implants represent an important strategy for providing instant and long-lasting volume enhancement to address both aging and posttraumatic defects. OBJECTIVE: To better understand risks of facial implants by examining national resources encompassing adverse events and considerations facilitating associated litigation. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study reviewed complications following facial implants. The procedures reviewed were performed on patients at locations throughout the United States from January 2006 to December 2016. Data collection was completed in March 2017. The Manufacturer and User Facility Device Experience database, which contains medical device reports submitted to the US Food and Drug Administration (FDA), was searched for complications that occurred from January 2006 to December 2016 involving facial implants made by Implantech, MEDPOR, Stryker, KLS Martin, and Synthes. Furthermore, the Thomson Reuters Westlaw legal database was searched for relevant litigation. MAIN OUTCOMES AND MEASURES: The complications of facial implants were analyzed in relation to the location of implant and severity of complication. Litigation was analyzed to determine which factors determine outcome. RESULTS: Thirty-nine instances of adverse events reported to the FDA were identified. Sixteen (41%) involved malar implants, followed by 12 chin implants (31%). The most common complications included infection (18 [46%]), implant migration (9 [23%]), swelling (7 [18%]), and extrusion (4 [10%]). Thirty-two patients (83%) had to have their implants removed. Infection occurred at a mean (SD) of 83.3 (68.8) days following the surgery. One-third of complications involved either migration or extrusion. The mean (range) time to migration or extrusion was 381.1 (10-2400) days. In 12 malpractice cases identified in publicly available court proceedings, alleged inadequate informed consent and requiring additional surgical intervention (ie, removal) were the most commonly cited factors. CONCLUSIONS AND RELEVANCE: Infection and implant migration or extrusion are the most common complications of facial implants. Most of these complications necessitate removal. These considerations need to be discussed with patients preoperatively as part of the informed consent process, as allegedly inadequate informed consent was cited in a significant proportion of resultant litigation, and there were overlapping considerations among adverse events reported to the FDA and factors brought up in relevant litigation. Cases resolved with settlements and jury-awarded damages encompassed considerable award totals. LEVEL OF EVIDENCE: NA.

In Vitro Cytotoxicity of Maxillofacial Silicone Elastomers: Effect of Nano-particles.

PURPOSE: Silicone elastomers are generally used for maxillofacial extraoral prostheses. The purpose of this in vitro study was to evaluate the cytotoxicity of different kinds of nanoparticles added to two types of maxillofacial elastomers. MATERIALS AND METHODS: A-2000 and A-2006 silicone elastomers were used. The silicone specimens were divided into eight groups according to the presence of additional nanoparticles (n = 18). The following represents the groups in the study: Group A: A-2000 silicone (control group); Group B: A-2006 silicone (control group); Group C: A-2000 silicone and the addition of titanium dioxide (TiO2 ); Group D: A-2006 silicone and the addition of TiO2 ; Group E: A-2000 silicone and the addition of fumed silica; Group F: A-2006 silicone and the addition of fumed silica; Group G: A-2000 silicone and the addition of silaned silica; Group H: A-2006 silicone and the addition of silaned silica. A paired sample t-test was used to analyze the cytotoxicity of each group after 24, 48, and 72 hours. RESULTS: Based on the results of the 24-hour analysis, the biocompatibility values of the (A-2006) fumed silica group were higher than those of the control groups. There was no statistically significant difference in A-2006 and A-2000 groups. The cytotoxicity values of the control groups and TiO2 (A-2000 silicone) elastomer groups increased at all test times; however, the cytotoxicity values of the TiO2 (A-2006), fumed silica (A-2006), silaned silica (A-2006), fumed silica (A-2000), and silaned silica (A-2000) groups increased significantly only from 24 to 48 hours. CONCLUSION: Nanoparticles of TiO2 , fumed silica, and silaned silica added to a commercial silicone-based elastomer used for fabrication of maxillofacial prostheses are nontoxic.

Solid Midfacial Implants: When Fillers Are Not Enough.

The aging process results in volumetric changes on multiple levels of the face including the skin, soft tissue, and underlying facial skeleton. Malar and mandibular augmentation with facial fillers and alloplastic implants are two treatment options used to achieve the goal of volume enhancement. Noninvasive modalities have become increasingly popular due to the availability of office-based options that require a limited understanding of facial aesthetics, a basic grasp of the mechanisms behind the aging process, and no level of surgical expertise or training. It is important, however, to understand the limitations and appropriate use of each technique, surgical and nonsurgical, either as a sole modality or in conjunction with each other to attain optimal aesthetic results. Although minimally invasive soft-tissue augmentation procedures such as fillers offer midface treatment options, alloplastic implants provide a stable support platform or scaffolding for skeletal and soft-tissue augmentation that fillers alone cannot often provide. A multilevel understanding of facial aesthetics must include the facial skeletal architecture and foundation that it provides for proper soft-tissue draping and contour. Alloplastic implants remain the standard for skeletal augmentation and remain the mainstay when fillers are not sufficient for midface augmentation.

Solid Implants in Facial Plastic Surgery: Potential Complications and How to Prevent Them.

Allogenic implants are an effective alternative to autologous grafts in the reconstruction of facial defects. These implants are used to reconstruct a variety of bony and soft-tissue defects, including the frontal and temporal regions; internal orbit; infraorbital rim; malar, paranasal, and nasal regions; mandible; and chin. In comparison to their autologous counterparts, alloplastic materials are more readily available, lack donor-site morbidity, decrease surgical time and cost, and still have relatively good postoperative tissue tolerance. However, these implants are not without their own spectrum of complications. Common solid implant materials include silicone, GoreTex (expanded polytetrafluorethylene; W. L. Gore & Associates Inc., Flagstaff, AZ), MedPor (high-density porous polyethylene; Porex Industries, Fairburn, GA), and Mersilene mesh (nonresorbable polyester fiber; Ethicon, Somerville, NJ). Each of these materials poses certain complication risks based on their surface contour (smooth vs. porous), pliability, and reactivity with surrounding tissue. In addition, certain implant locations within the head and neck are at risk for different postoperative complications. Although there are no evidence-based guidelines for implant reconstruction to help avoid common complications, there are several principles and techniques that are commonly employed by surgeons to help reduce complication rates. These include careful patient selection, proper choice of operative procedure, infection control practices (including pre/intraoperative systemic antibiotics, meticulous aseptic technique, impregnation/soaking of implant in antibiotic, irrigation of implant pocket with antibiotic, careful closure of tissue layers, and postoperative oral antibiotics), preoperative implant shaping, choice of surgical approach, and intraoperative surgical techniques. Larger, controlled trials are needed to confirm the efficacy of the aforementioned techniques in the reduction of postoperative complications.

Prótese óculopalpebral com captação de movimento palpebral: proposta de dispositivo mecânico / Oculopalpebral prosthesis with eyelid motion capture: mechanical appliance proposition

Introdução: A reconstrução de grandes defeitos da face nem sempre é passível de correção cirúrgica, podendo ser restaurados com as próteses faciais. Apesar da prótese óculopalpebral apresentar uma aparência natural, ela é facilmente notada, pois não apresenta os movimentos palpebrais de abertura e fechamento sincronizadas com o olho contralateral, tornando assim a reconstrução protética um grande desafio. Objetivos: Planejar, desenhar, viabilizar e construir um protótipo com recurso mecânico/elétrico possibilitando sincronia dos movimentos palpebrais com o olho sadio para utilização em prótese óculopalpebral. Material e Métodos: Confecção de uma prótese óculopalpebral com um dispositivo de pálpebra móvel em silicone médico capaz de conectar-se a um sistema mecânico-elétrico responsável por realizar movimentos de abertura e fechamento da pálpebra móvel da prótese. Resultados e Discussão: Foi confeccionada uma prótese óculo-palpebral em resina acrílica termicamente ativada, criando-se um nicho para a acomodação de um sistema elétrico e possibilitar a livre movimentação de uma fina pálpebra em silicone interligada ao dispositivo tornando possível a conexão desse sistema com um sensor que capta o movimento palpebral de um olho saudável. Conclusão: No presente estudo um protótipo mecânico - elétrico foi planejado, desenhado e desenvolvido acoplado a uma prótese óculopalpebral estabelecendo e sincronizando seus movimentos palpebrais com o olho sadio.

Introduction: Surgical reconstruction of large facial defects may not be always possible. Extraoral maxillofacial prosthesis are a good restorative option. Even though when the oculopalpebral prosthesis presents a natural appearance, it can be easily noticed because its eyelids do not move. It is desirable for the eyelids to open and close synchronously with contralateral eye. Thus, prosthetic reconstruction of oculopalpebral region is a great challenge. Objectives: To plan, design, enable and build a oculopalpebral prosthesis prototype with mechanical and electric features allowing eyelid motion with synchronization with the sound eye. Material and method: Fabrication of an oculopalpebral prosthesis with a medical grade silicone movable eyelid which has the capability to connect itself to an mechanical-eletrical system responsible to make opening and closing movements on prosthesis movable eyelid. Results and discussion: An oculopalpebral prosthesis was made in thermoactivated acrylic resin. A gap was created to accomodate an electrical system and also allow free motion of a thin silicone eyelid attached to the dispositive. This system can be connected to a sensor which captured the eyelid motion of a sound eye. Conclusion: A mechanical-electrical prototype was planned, designed and developed attached to an oculopalpebral prosthesis stablishing and synchronizing its eyelid movements with the sound eye.

Complications, risk factors, and failures of immediate functional loading of implants placed in the completely edentulous maxillae: a report of 3 consecutive cases.

PURPOSE: The aim of this article was to document the failure of immediate functional loading of implants placed in 3 consecutive completely edentulous maxillae to analyze the possible causes, risk factors, and how to avoid the complications that occur due to this procedure. MATERIALS AND METHODS: Six implants with standardized length and diameter were placed in 3 consecutive patients with completely edentulous maxillae in the canine, premolar, and molar region bilaterally and flaplessly using computer-guided surgical guides. Screw-retained conversion maxillary prostheses were delivered immediately after the surgery. RESULTS: Patients complained from severe to moderate pain. For the first and second patients (P1 and P2), 4 implants per patient were lost during the second week after implant surgery, whereas 5 implants were lost during the third week after implant surgery for the third patient (P3). CONCLUSION: This high failure rate presented in this report may be explained by 1 or more of the following reasons: poor maxillary bone quality, nonaxial loading of the implants, nonrigid splinting material, high forces delivered from the opposing dentition, and/or patients with para-functional habits.

Electroconvulsive therapy after maxillofacial metallic implants.

A growing body of literature suggests that electroconvulsive therapy (ECT) can be safely utilized in patients with craniofacial metallic implants. Here we provide radiographic images and the clinical course of a 49-year-old woman with both maxillary and mandibular metallic implants who safely received ECT.

Differences of salivary cortisol levels between long-term and short-term wearers of dento-maxillary prosthesis due to head and neck cancer resection.

PURPOSE: The purpose of this study was to use cortisol awakening response (CAR) to investigate the differences in daily life stress experienced by individuals wearing either a long-term (LT) or a short-term (ST) dento-maxillary prosthesis following head and neck cancer (HNC) resection. Also we used the University of Washington Quality of Life (UW-QOL) version 4 questionnaire to evaluate the differences in quality of life (QOL) scores between ST and LT wearers of a dento-maxillary prosthesis. METHODS: Salivary samples were collected from 11 LT and 10 ST prosthesis wearers on two consecutive days at two time points, immediately after waking up (T0) and 30min later (T30), by passive drool collection. Cortisol levels were measured using a high sensitivity salivary cortisol enzyme immunoassay kit (Salimetrics, LLC, State College, PA, USA) and CAR (the differences between the cortisol levels at T0 and T30) was compared between LT and ST prosthesis wearers. In addition, both the groups completed the UW-QOL questionnaire and the scores were compared. RESULTS: A significant difference was observed in CAR between the two groups. CAR of the ST prosthesis wearers was significantly lower compared with that of the LT prosthesis wearers; moreover, the ST prosthesis wearers revealed significantly lower total UW-QOL scores and there were significant differences in appearance, activity, recreation, speech, and anxiety. CONCLUSION: Within the limitations of this study, the findings suggest that individuals wearing ST dento-maxillary prostheses following HNC resection experience some sort of daily life stress and complicated socio-demographic factors may influence their QOL.

Evaluación de la deformación de dos siliconas para prótesis faciales, influencia de la pigmentación y desinfección química / Assessment of initial and the permanent deformation of two silicones (Silved Selant and Brascoved) for facial prostheses under the pigmentation and chemical disinfection influence

La propuesta de este estudio fue analizar el efecto de la pigmentación y de la desinfección química sobre la deformación inicial y permanente de dos siliconas (Silved Selant y Brascoved) utilizadas en la confección de prótesis faciales. Las muestras para los analisis de deformación inicial y permanente (20 mm × 12,5 mm) fueron confeccionadas de acuerdo con las instrucciones del fabricante. Para cada silicona (n= 40), diez muestras fueron pigmentadas con polvo de maquillaje, diez con óxido de hierro, diez con polvo de cerámica y diez sin pigmentación. Cinco muestras de cada grupo fueron sometidas a desinfección química, con clorhexidina al 2 por ciento por aspersión. Todas las muestras fueron inmersas en suero fisiológico y almacenado en estufa a 35 º ± 1 ºC. Después de 90 días, las muestras fueron sometidas a los exámenes de deformación inicial y permanente. Para ambas propiedades, los datos fueron analizados por el test de Tukey (a= 0,05). Los resultados mostraron que todos los materiales presentaron deformación inicial y permanente independiente de la desinfección química y pigmentación. Los grupos pigmentados con óxido de hierro fueron los que presentaron menor deformación, inicial y permanente, cuando fueron sometidos a desinfección química, independientemente de la silicona usada(AU)

The purpose of present study was to analyze the effect of pigmentation and chemical disinfection on the initial and the permanent deformation of two silicones (Silved Selant and Brascoved) for facial prosthesis. Initial and permanent deformation tests samples (20 mm × 12.5 mm) were made following the manufacturer's instructions. For each silicone (n= 40), ten samples were used for pigmentation with make up power, ten with iron oxide, ten with ceramics power and tem were tested without pigmentation. Five samples of each group were submitted to chemical disinfection using a 2 percent Chlorhexidine spray. All samples were immersed in physiological saline and stored in an oven at 35 º ± 1 ºC. After 90 days, the samples were submitted to initial and permanent deformation tests using a dial indicator. For both properties, data were analyzed by Tukey's test (a= 0.05). The results showed that all the materials had initial and permanent deformation regardless of pigmentation and chemical disinfection. The groups were used for pigmentation with iron oxide showed less initial and permanent deformation when were submitted to the chemical disinfection regardless the silicone used(AU)

Relationship between medical treatment and oral dryness diagnosed by oral moisture-checking device in patients with maxillofacial prostheses.

PURPOSE: This study aimed to examine the relationship between oral dryness and medical treatment (medication, radiotherapy) for patients with maxillofacial prostheses. METHODS: Sixteen patients with maxillofacial prostheses were examined according to the following procedure. For evaluating oral dryness, oral moisture was measured at the lingual mucosa and the right and left buccal mucosa using a Moisture Checker Mucus. The mean value of each measurement was recorded as the moisture value (%). A value of 29% was used as a reference value to divide patients into a normal group and an oral dryness group. Patients with a moisture value of more than 29% were classified as normal. The clinical histories of the patients (including their current medication use and radiotherapy history-dose of radiation and period after radiation) were surveyed from their clinical records. Patients rated themselves on their feelings for oral dryness using a faces scale. RESULTS: The moisture value was significantly lower in the oral dryness group than the normal group. There was a significant difference in moisture values between the number of patients with and without radiotherapy, but not patients with and without medications. The moisture value had a significant negative correlation with the dose of radiation and a positive one with the period after radiation. The score of faces scale showed a significant negative correlation with moisture value. CONCLUSION: The patients with maxillofacial prostheses who had undergone radiotherapy need moisture retention because of oral dryness depending on the dose of radiation and the period after radiation.

Structural damages of maxillofacial biopolymers under solar aging.

Additional types of silicone biopolymers are widely used in maxillofacial prosthetics. Therefore, the knowledge of the solar radiation's effect on their structural stability is highly important. Four different industrially synthesized biomaterials were examined, called Episil Europe 1, Europe 2, Europe 3 and Africa 3, which were exposed to solar radiation (UVA, UVB) for eight different time periods (from 8 to 168 h). Structural damages due to irradiation exposure were investigated by mechanical tests (compression) and differential scanning calorimetry (DSC) methods. Simple mathematical models were developed, containing parameters with physical meaning such as maximum stress (sigma(max)), maximum strain (epsilon), elasticity parameter (E), and viscoelastic parameter (p), for the compression test, and melting temperature (T (m)) and Enthalpy in melting point (Heat) for DSC. With increasing irradiation time their maximum stress and strain decreased significantly, and the materials lost their elasticity and molecular stability. A decrement in their melting points and heats was observed as irradiation time was increasing. Finally, experimental results demonstrated that solar radiation has a severe effect on the structural stability of the examined biomaterials.

A study of 25 zygomatic dental implants with 11 to 49 months' follow-up after loading.

PURPOSE: The purpose of this study was to evaluate indications, surgical problems, complications, and treatment outcomes related to the placement of zygomatic implants. A second aim was to determine any prosthetic difficulties and complications. MATERIALS AND METHODS: Twenty-five zygomatic implants were placed in 13 patients between April 1999 and December 2001. The patient age range was between 49 and 73 years, with a mean age of 59 years. All patients showed severe resorption of alveolar bone in the maxilla. All but 2 patients were smokers. Two patients had a history of cleft palate surgery, and 2 patients were known to be bruxers. Standard recommended surgical protocol was followed, and treatment was performed under general anesthesia. After abutment surgery, 9 patients received bar-retained overdentures, and 4 patients received fixed prostheses. RESULTS: No implants were lost, and few surgical complications were experienced. The follow-up period was 11 to 49 months. DISCUSSION: Although surgical problems precipitated by difficult anatomy in cleft patients and a patient with reduced interarch access were experienced, the results were favorable. Fabricating a functional and esthetic prosthesis can be a challenge. CONCLUSION: Zygomatic implants provide a treatment option for patients with severe maxillary resorption, defects, or situations where previous implant treatment has failed. In this experience, treatment with zygomatic implants was a predictable method with few complications, even in a group of patients that would not be considered ideal for implant treatment.

A hollow-bulb interim obturator for maxillary resection. A case report.

The treatment of hemimaxillectomy patients include the construction of an interim obturator in the wound healing period. With the aim of simplifying this process, we describe construction of an obturator in a short single visit, in the dental chair with no need for impressions or for laboratory services. The obturator comprises: (i) the surgical obturator and (ii) a hollow light-cured resin bulb built onto the base, and providing a large surface for bonding of the soft reline material. The advantages of this approach are rapid construction and ease of ongoing adjustment during the healing process.

Necesidad de prótesis buco-maxilofacial en el municipio Matanzas en el año 1999 / Need for oral-maxillofacial protheses in Matanzas municipality in the year 1999

Se realizó este trabajo con el objetivo de conocer la necesidad de prótesis buco-máxilo-facial en el municipio Matanzas, así como el comportamiento de estas y su relación con el sexo, la edad y la etiología. Se realizó un estudio descriptivo de corte transversal donde se tomó como referencia la población perteneciente a las distintas áreas de salud de este municipio. Para la obtención de la muestra se aplicó un diseño muestral estratificado por conglomerado, la cual quedó constituida por 1 937 personas, y a aquellas que reunieron los criterios de inclusión, se les aplicó la encuesta de necesidad de rehabilitación buco-maxilofacial. Se obtuvo como resultado que existía necesidad de prótesis buco-maxilofacial con preferencia por la del tipo ocular, sexo masculino y pacientes jóvenes. La etiología traumática fue la predominante como causa de lesión para ambos sexos, seguida por la oncológica. Las regiones auriculares y maxilares estuvieron afectadas en el sexo masculino en mayor cuantía que en el femenino. En las regiones orbital, nasal, mandibular y compleja no hubo afectaciones(AU)

This paper was aimed at finding out the need for oral-maxillofacial prostheses in Matanzas municipality as well as the performance of these appliances and their relation with sex, age and etiology. A cross-sectional descriptive study was made in which the population cared for by the different health care areas of this municipality was taken as reference. A stratified sampling design by conglomerates was applied to obtain a sample, finally composed of 1937 persons and those who met the inclusion criteria were administered the Oral-maxillofacial rehabilitation requirement survey. The results showed that the ocular oral maxillofacial prosthesis was the one that males and young patients preferred most. Trauma lesion was the predominant cause for both sexes followed by oncological problems. Auricular and maxillary regions were more affected in males than in females. No effects were seen in orbital, nasal, mandibular and complex regions(AU)