Termo de consentimento livre e esclarecido e sua relação com os procedimentos de preenchimento labial / Free and informed consent terms and its relationship with lip filling procedures

Introdução: Na medida em que envelhecemos os lábios estreitam-se, ocasionando perda de volume e contorno e como forma de minimizar este efeito fisiológico o preenchimento labial de escolha utilizado é o ácido hialurônico. É possível perceber efeitos adversos advindos do emprego deste material, e pelo fato da informação ao paciente ser assegurada pelo Código de Defesa do Consumidor e pelo fato da necessidade dos Cirurgiões-Dentistas terem de esclarecer seus pacientes, o Termo de Consentimento Livre e Esclarecido tornase necessário. Objetivo: identificar, por meio de aplicação de questionário, a percepção de profissionais que trabalham com Harmonização Orofacial em relação a necessidade do emprego do Termo de Consentimento Livre e Esclarecido (TCLE). O questionário apresentou 6 perguntas objetivas, que foram disponibilizadas na plataforma Google Forms®. Material e Método: os dados obtidos foram tabulados em uma planilha eletrônica do programa Microsoft Excel e após analisados descritivamente através de tabelas de frequência, porcentagens e gráficos estatísticos. Resultados: dentre os entrevistados foi constatado que a maioria, 87,5% dos especialistas em Harmonização Orofacial realizam o procedimento de preenchimento labial em sua rotina clínica, e 12,5% não. Conclusão: no presente estudo identificamos que os especialistas realizam o emprego do TCLE, em sua maioria, porém, alguns destes ainda negligenciam o seu uso(AU)

Introduction: As we age, the lips become thinner and to minimize this effect, the lip filler used is hyaluronic acid. It is possible to notice adverse effects arising from the use of this material, and it is extremely important that Dental Surgeons have to clarify their patients, the Free and Informed Consent Form becomes necessary. Objective: to identify, through the application of a questionnaire, the perception of professionals who work with Orofacial Harmonization in relation to the need to use the Free and Informed Consent Form (TCLE). The questionnaire presented 6 objective questions, which were made available on the Google Forms® platform. Materials and Methods: the data obtained were tabulated in a Microsoft Excel spreadsheet and then analyzed descriptively using frequency tables, percentages and graphs. Results: among those interviewed, it was found that the majority, 87.5% of specialists in Orofacial Harmonization perform the lip filling procedure in their clinical routine, and 12.5% do not. With the high percentage of 59.4%, it was possible to verify that the majority of professionals perform 1 to 3 procedures per month; 31.3% perform 4 to 9 procedures per month; and 9.4% of 10 or more monthly procedures. Conclusion: in the present study it was possible to identify that the majority of specialists in Orofacial Harmonization use the informed consent form, however, some of them still neglect its use(AU)

LC-OCT as a tool to visualize in vivo location of dermal fillers.

BACKGROUND: Dermal fillers have emerged as a popular non-surgical solution for facial rejuvenation and enhancement. Apart from botulinum toxin injections, they are the most common non-surgical procedure performed in the US. Line-field optical coherence tomography (LC-OCT; deepLive system Damae Medical, France) represents one of the most recent developments in non-invasive skin imaging technologies. MATERIALS AND METHODS: We performed LC-OCT image acquisition on six patients that were treated with hyaluronic acid (HA) dermal fillers in various locations on the face. The images were acquired before the application of the fillers (T0), immediately after (T1), and at a 6- to 8-week (T2) follow-up visit. RESULTS: At T0, we were able to appreciate a normal-appearing epidermis, dermoepithelial junction, and dermis. At T1, the intradermal filler deposits appeared as homogeneously hyporeflective areas, clearly discernible from surrounding vessels and other structures. At T2, the deposits were distinguishable as hyporeflective areas, although they were diminished in size compared to T1. On enface view, collagen fibers had increased thickness and were more homogeneously organized and hyperreflective. CONCLUSIONS: We established the usefulness of LC-OCT in the non-invasive evaluation of dermal HA fillers to visualize both short-term and medium-term effects. LC-OCT may be a valuable tool in evaluating the precise location of filler placement and follow-up of resulting in vivo changes.

Clinical improvement after removal of hypercalcemia-causing granulomas.

In this report, we present the case of a woman with clinical characteristics of hypercalcemia due to ectopic production of 1,25(OH)2D. She reported a history of aesthetic surgery with gluteal fillers. The formation of granulomas after these interventions were previously described. In this case, surgical removal of the foreign formations was attempted with clinical stability during 3 years.

Presentamos el caso de una mujer con características clínicas de hipercalcemia secundaria a la producción ectópica de 1,25(OH)2D. La paciente informó una historia de rellenos glúteos con fines estéticos. La formación de granulomas posterior a este tipo de intervenciones fue previamente descrita por otros autores. En este caso se intentó la extirpación quirúrgica de las formaciones extrañas con estabilidad clínica durante 3 años.

INDIVIDUAL ARTICLE: Skincare in Skin of Color: A Comprehensive Approach to Preprocedure, Intraprocedure, and Postprocedure.

Hyperpigmentation, uneven skin tone, textural changes, and dull skin are common cosmetic concerns in skin of color. Other signs of aging, including fine lines, deeper wrinkles, and skin laxity, also occur but may present in later decades. In-office procedures such as laser treatments, energy devices, toxins, fillers, and chemical peels are useful options for addressing the most common cosmetic concerns in skin of color patients. Skincare can play an important role in improving cosmetic outcomes when used in conjunction with in-office procedures. With the availability of these approaches, clinicians can now integrate in-office procedures with skincare strategies to offer patients with skin of color a comprehensive treatment plan that meets their needs. J Drugs Dermatol. 2024;23:8(Suppl 1):s5-10.

Enhancing Facial Filler Training with 3D-Printed Models: A Prospective Observational Study on Medical Student Competence.

BACKGROUND This study evaluated the efficacy of 3-dimensional (3D) printed facial models in training medical students for cosmetic facial filler applications. A prospective observational study included 40 medical faculty students without prior filler application or surgical training. They received theoretical and practical training using 3D-printed face models, assessed through pre- and post-training surveys. MATERIAL AND METHODS Facial models were designed using SolidWorks and printed with a Mars 2 PRO 3D printer using PLA filament and high-performance silicone. Training comprised in-class instruction, live demonstrations, hands-on practice, and individual guidance. Students' skills were assessed through self-assessments and objective criteria. RESULTS After training, students showed significant improvement in procedural understanding and application locations, with increased confidence and competence (P<0.001). Statistical analysis confirmed these improvements. CONCLUSIONS 3D-printed facial models are valuable for enhancing medical students' skills in cosmetic facial fillers, offering cost-effective and safe simulation. This approach improves practical skills and confidence, benefiting medical education and patient care.

Neurotoxins and Combination Therapies.

BACKGROUND: Facial aging involves multilevel changes, extending from the skin to deep support structures. A comprehensive treatment approach targeting the many aspects of facial dynamics and architecture is often necessary to achieve optimal correction, prevent changes before they occur, and/or help highlight inherited features. OBJECTIVE: To explore the integration of botulinum toxin type A (BoNT-A) into multimodal aesthetic treatment plans. MATERIALS AND METHODS: This article reviews evidence supporting the combination of BoNT-A with other minimally invasive cosmetic therapies, including dermal fillers, lasers, and energy-based devices as well as with plastic and reconstructive surgeries for more controlled healing and improved scar cosmesis. RESULTS: Combination treatment protocols including BoNT-A demonstrate higher patient satisfaction and retention rates compared to monotherapy or sequential treatments. Some guidelines for sequencing of treatments exist, but evidence is scant with certain combinations. CONCLUSION: Integrating BoNT-A into a larger aesthetic treatment plan is crucial for achieving natural and satisfying results in facial rejuvenation. Evidence supports better outcomes when incorporating with both surgical and nonsurgical modalities. Understanding how to address anatomy over time through different aesthetic therapies together allows for individually tailored, more deeply impactful treatment plans.

A Prospective, Multicenter, Evaluator-Blinded, Randomized Study of Diluted Calcium Hydroxylapatite to Treat Decollete Wrinkles.

BACKGROUND: Calcium hydroxylapatite (CaHA) dermal filler is used for a variety of aesthetic treatments; however, the safety and effectiveness of diluted CaHA for the treatment of décolleté wrinkles have not been established. OBJECTIVE: To demonstrate the effectiveness and safety of diluted CaHA (Radiesse; 1:2 CaHA:saline) injection for the improvement of décolleté wrinkles in females. METHODS: Eligible females with moderate or severe ratings on the Merz Aesthetic Scale (MAS) Decollete Wrinkles - At Rest received up to 3 injection cycles of diluted CaHA either 8 weeks apart (3 injection cycles) or 16 weeks apart (2 injection cycles). Effectiveness was evaluated by improvement on the MAS. Adverse events were recorded over a 52 week period. RESULTS: Sixteen weeks after the last treatment, the response rate (1-point improvement or greater) on the MAS Decollete Wrinkles - At Rest was 73.5% (P<0.0001; pooled sample) for all patients. The use of diluted CaHA in the decollete also demonstrated a favorable safety profile. CONCLUSIONS: Diluted CaHA is a safe and effective treatment for the improvement of decollete wrinkles in females.J Drugs Dermatol. 2024;23(7):551-556.  doi:10.36849/JDD.8261.

Intracorporeal evaluation of hyaluronic acid fillers with varied rheological properties and correlations with aesthetic outcomes.

BACKGROUND: Understanding the differences in soft tissue filler rheology and how these properties can impact clinical results is a fundamental concepts for any injector. This study aimed to assess the tissue integration characteristics of hyaluronic acid (HA) fillers manufactured with different technologies (Non-Animal Stabilized HA [HA-N] or Optimal Balance Technology [HA-O]) using ultra-high-frequency ultrasound. METHODS: Twelve female participants with mild-to-moderate midface volume loss and temporal hollowing were enrolled and treated with HA-N and/or HA-O. Participants were seen at five visits (screening/baseline [treatment], and Weeks 1 [optional touch-up], 4, 6, and 8 [follow-up visits]). Ultrasound was used to evaluate the degree of product integration. RESULTS: On ultrasound, HA-N presented with distinct borders, minimal tissue integration, and a capacity to displace tissues. Conversely, HA-O tended to spread horizontally within the same tissue plane and integrated within tissues. The volumizing capacity of the HA-O fillers was dependent on particle size. CONCLUSION: HA-N is suited for deep injections in areas such as the upper lateral cheek and under the muscle of the temporal region when a lifting effect is desired; HA-O is best suited for subcutaneous injections, in areas of dynamic movement or for patients with thin skin; and can be injected subcutaneously or supraperiosteally when a volumizing effect is desired.

Engineering a durable BDDE cross-linked collagen filler for skin rejuvenation.

Skin aging, characterized by reduced regeneration, chronic inflammation, and heightened skin cancer risk, poses a significant challenge. Collagen fillers have emerged as a potential solution for skin rejuvenation by stimulating collagen regeneration. However, their clinical efficacy is limited by inherent instability and vulnerability toin vivodegradation by collagenase. Chemical cross-linking presents a promising approach to enhance stability, but it carries risks such as cytotoxicity, calcification, and discoloration. Here, we introduce a highly durable 1,4-butanediol diglycidyl ether (BDDE) cross-linked collagen filler for skin rejuvenation. BDDE effectively cross-links collagen, resulting in fillers with exceptional mechanical strength and injectability. These fillers demonstrate favorable stability and durability, promoting proliferation, adhesion, and spreading of human foreskin fibroblast-1 cellsin vitro. In vivostudies confirm enhanced collagen regeneration without inducing calcification. BDDE cross-linked collagen fillers offer promising prospects for medical cosmetology and tissue regeneration.

Stem Cell-Derived Extracellular Vesicle-Bearing Injectable Hydrogel for Collagen Generation in Dermis.

Despite the remarkable advances of dermal fillers that reduce wrinkles caused by dermis thickness reduction, they still lack effective hydrogel systems that stimulate collagen generation along with injection convenience. Here, we develop a stem cell-derived extracellular vesicle (EV)-bearing thermosensitive hydrogel (EVTS-Gel) for effective in vivo collagen generation. The TS-Gel undergoes sol-gel transition at 32.6 °C, as demonstrated by the storage and loss moduli crossover. Moreover, the TS-Gel and the EVTS-Gel have comparable rheological properties. Both hydrogels are injected in a sol state; hence, they require lower injection forces than conventional hydrogel-based dermal fillers. When locally administered to mouse skin, the TS-Gel extends the retention time of EVs by 2.23 times. Based on the nature of the controlled EV release, the EVTS-Gel significantly inhibits the dermis thickness reduction caused by aging compared to the bare EV treatment for 24 weeks. After a single treatment, the collagen layer thickness of the EVTS-Gel-treated dermis becomes 2.64-fold thicker than that of the bare EV-treated dermis. Notably, the collagen generation efficacy of the bare EV is poorer than that of the EVTS-Gel of a 10× lesser dose. Overall, the EVTS-Gel shows potential as an antiaging dermal filler for in vivo collagen generation.

A 52-week follow-up, multi-center, randomized, double-blinded comparison of efficacy and safety of two hyaluronic acid fillers for the treatment of moderate-to-severe nasolabial folds in Chinese population.

INTRODUCTION: To investigate the efficacy and safety of Cutegel® MAX (Cutegel) in the correction of moderate-to-severe nasolabial folds (NLFS) compared to Restylane® (Restylane, control). METHODS: This study was a 52-week, multicenter, randomized, double-blinded, active-controlled clinical trial. Qualified participants with moderate-to-severe NLFs were randomly assigned in a 1:1 ratio to receive Cutegel or Restylane. For the primary efficacy endpoint, the response rate was defined as the percentage of subjects exhibiting an improvement of at least one-point based on blinded evaluation of Wrinkle Severity Rating Scale (WSRS) at 24 weeks after injection. Other secondary efficacy endpoints and treatment-emergent adverse events (TEAEs) were assessed. RESULTS: Of 340 subjects randomized, 317 completed the week 52 visit. In the per protocol set (PPS), the blinded evaluator-assessed response rates at week 24 were 81.17% for Cutegel versus 77.56% for Restylane (p = 0.327). The between-group treatment differences in response rates were 3.60% [95% confidence interval (CI) = (-5.39%, 12.60%)], which demonstrated the noninferiority of Cutegel. Other secondary efficacy endpoints supported this. No significant differences were observed in the occurrence of adverse events between the two groups. CONCLUSION: Similar to Restylane, Cutegel was effective and well tolerated in correcting moderate-to-severe NLFs among the Chinese population.

Nasolabial folds (NLFs) are among the early indicators of facial aging process. In the past, rhytidectomy has been considered a safe procedure, yet it continues to carry risks such as hematoma, skin necrosis, nerve injury, and infection. With the ongoing development of biomaterials including hyaluronic acid (HA), minimally invasive injection procedures for the aesthetic correction of NLFs have become the preferred choice in recent years. The widespread use of HA has resulted in the development of various types of commercial HA fillers, such as Cutegel and Restylane. It is well known that HA filler products produce varying effects, attributable to differences in their components and physical properties. Previous studies have established that Restylane is a safe and effective HA dermal filler for the correction of NLFs. However, there is a lack of studies on both the cosmetic results and safety data for Cutegel in the published literature. Therefore, a randomized, double-blinded, active-controlled clinical trial was conducted at seven Chinese hospitals to evaluate the efficacy and safety of Cutegel for the correction of moderate-to-severe NLFs, compared to the approved Restylane in China. Among the 340 randomized subjects, 170 subjects received Cutegel, and 169 subjects received Restylane. Both groups reported similar improvements in WSRS (the between-group treatment differences in response rates exceeded the prespecified noninferiority margins), and also in other efficacy evaluations. Additionally, the two treatment groups showed similar safety profiles. In summary, Cutegel proved to be well tolerated and effective in this randomized, active-controlled clinical study, demonstrating its noninferiority to Restylane and validating its use as an alternative treatment for Chinese subjects with moderate-to-severe NLFs.

The role of oculoplastic surgeons in minimally invasive cosmetic injectables.

PURPOSE OF REVIEW: In recent years, the field of aesthetic medicine has witnessed a paradigm shift with an increasing demand for minimally invasive cosmetic procedures, including cosmetic injectables. This review aims to delineate the distinctive role played by oculoplastic surgeons in the administration of cosmetic injectables, comparing their expertise to that of nonphysician practitioners. RECENT FINDINGS: Complications arising from cosmetic injections are discussed, including skin discoloration, inflammation, necrosis, vision loss, retinal pathology, and central nervous system adverse effects. Injector expertise, patient factors, type of filler, location of injection, and management strategies are reviewed. Findings highlight diverse practitioner involvement, common adverse effects like skin necrosis and vision loss, with hyaluronic acid fillers being prominent. Areas at the highest risk for ocular complication include the glabella and nose with potential management involving dissolving fillers and reducing pressure. Emphasis is placed on expert injector selection and patient awareness. SUMMARY: The administration of cosmetic injectables requires a profound understanding of facial anatomy, vasculature, and potential complications. In contrast to nonphysician practitioners, oculoplastic and aesthetic surgeons bring a level of anatomical precision and clinical acumen that is essential for navigating the complexities of cosmetic injectables. Emphasis on training and collaboration among practitioners will be essential in advancing the field while prioritizing patient safety and satisfaction.

In Vitro Cytocompatibility Analysis and Comparison of Different Hyaluronic Acid Fillers for Minimally Invasive Esthetics.

BACKGROUND/AIM: To overcome the natural visual consequences of the physiological aging process, the use of biodegradable fillers made of hyaluronic acid or sodium carboxymethyl cellulose is increasingly popular in modern esthetic medicine. Clinicians can choose from a wide range of fillers with variable compositions and rheological properties, and therefore with different application areas and injection depths. The aim of this study was to analyze and compare the most commonly used fillers for facial augmentation regarding their in vitro biocompatibility and to find potential correlations to their rheological properties. MATERIALS AND METHODS: In the present study, direct and indirect in vitro cytotoxicity analysis according to DIN EN ISO 10993-5 were performed on 39 different filler materials for facial augmentation. RESULTS: All fillers analyzed in this study overall showed satisfactory results in the direct and indirect cytocompatibility tests. While no material was outside the threshold values in the 2,3-bis-(2-methoxy-4-nitro-5-sulphenyl)-(2H)-tetrazolium-5-carboxanilide (XTT) cell viability and bromodeoxyuridine (BrdU) cell proliferation assays or in the live-dead staining, only 7 out of the 39 fillers reached the required values in the lactate dehydrogenase assay. CONCLUSION: All biodegradable fillers examined in this study were found to be sufficiently cytocompatible. Although the qualitative analysis of the test results showed differences between the fillers, no concrete correlation between test performance and composition or manufacturer of the fillers was found. Future efforts are required to provide clinicians with even better support in choosing the right filler for optimal outcome and patient satisfaction.

Facial Implants in Male Rejuvenation.

Many different methods achieve male facial augmentation. Arranged from shorter- to longer-term results, these methods include filler, fat/tissue grafting, fat/tissue transposition, and alloplastic implants. This study solely reviews allografts, which provide the most predictable hard-tissue augmentation. An array of alloplasts will be discussed in this study including chin, cheek, mandibular angle, frontal, and temporal implants. The most common and severe complications will also be explored with preventative and treatment algorithms.

Male Rejuvenation: Injectables.

The use of injectables can effectively treat the areas of greatest facial esthetic concern in males. Due to significant differences in the facial anatomy of men compared to women, treatment strategy, dosage, and technique differs. This article will review the pharmacology, preparation, pertinent anatomy, technique, risks, and adverse events associated with injectable agents emphasizing unique differences in male anatomy and esthetics.

Poly-l-lactic acid microspheres delay aging of epidermal stem cells in rat skin.

Objective: Injectable skin fillers offer a wider range of options for cutaneous anti-aging and facial rejuvenation. PLLA microspheres are increasingly favored as degradable and long-lasting fillers. The present study focused solely on the effect of PLLA on dermal collagen, without investigating its impact on the epidermis. In this study, we investigated the effects of PLLA microspheres on epidermal stem cells (EpiSCs). Methods: Different concentrations of PLLA microspheres on epidermal stem cells (EpiSCs) in vitro through culture, and identification of primary rat EpiSCs. CCK-8 detection, apoptosis staining, flow cytometry, Transwell assay, wound healing assay, q-PCR analysis, and immunofluorescence staining were used to detect the effects of PLLA on EpiSCs. Furthermore, we observed the effect on the epidermis by injecting PLLA into the dermis of the rat skin in vivo. Results: PLLA microspheres promote cell proliferation and migration while delaying cell senescence and maintaining its stemness. In vitro, Intradermal injection of PLLA microspheres in the rat back skin resulted in delayed aging, as evidenced by histological and immunohistochemical staining of the skin at 2, 4, and 12 weeks of follow-up. Conclusion: This study showed the positive effects of PLLA on rat epidermis and EpiSCs, while providing novel insights into the anti-aging mechanism of PLLA.

Anti-aging trends in Australia.

Anti-aging trends in Australia have changed considerably since the country emerged from the lockdowns associated with the SARS-Cov2 pandemic. People now rely on social media influencers for skin care advice and skin care products, including professional skin care treatments that can be purchased on Internet platforms. The quest for the perfect 'zoom face' led to a 300% rise in cosmetic procedures across Australia in the year to April 2021. People now want to use less products on their skin, while looking healthy and natural (termed 'skin minimalism'). The popularity of retinoid derivatives for preventing wrinkles has been superseded by non-irritating actives like hyaluronic acid (HA) and niacinamide that provide skin barrier protection, skin hydration, plumping and anti-inflammatory effects. Botulinum toxin injections remain the most popular non-surgical cosmetic procedure, followed by HA fillers, and biostimulators that promote the synthesis of collagen and give longer lasting but more gradual results than HA fillers. Laser resurfacing is widely used for epidermal resurfacing and skin tightening, as well as non-ablative lasers, intense pulsed light and radiofrequency or ultrasound skin tightening devices. Superficial chemical peels are still popular because they are relatively gentle, inexpensive, and require no downtime, whereas medium-to-deep chemical peels have largely been superseded by laser technology. However, the most efficient approach to prevent skin aging is adopting a healthy lifestyle and taking action against all factors of the skin aging exposome.