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)

Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion.

BACKGROUND: A hyaluronic acid (HA) filler intended for non-surgical improvement of chin appearance should ideally be of high strength/firmness (high G') to allow for deep injections on the bone. HASHA (Restylane Shaype) is a new hyaluronic acid (HA) injectable with high G' and high HA concentration (25 mg/mL), engineered by the new NASHA-HD (High Definition) technology. HASHA is suitable to be placed periosteally, aiming to mimic the natural shape of the bony chin. This pivotal clinical investigation evaluated effectiveness and safety of HASHA for augmentation and correction of chin retrusion.  Methods: Subjects 18 years or older with mild or moderate chin retrusion by the Galderma Chin Retrusion Scale (GCRS), were randomized 3:1 to HASHA (n=103) or no treatment (n=37). Assessments included GCRS (blinded evaluator), aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), subject satisfaction, and safety.  Results: GCRS responder rate (1-grade or greater improvement from baseline) was significantly higher for HASHA (83.3%) versus controls (10.8%) at month 3 (P<0.001) and maintained through month 12 (P<0.001). Aesthetic improvement was high throughout the study in the HASHA group, according to investigators (97% or greater) and subjects (89% or greater). Overall, subject satisfaction was high at month 3 and maintained at month 12. Product- or injection-related adverse events were mostly mild or moderate and transient. No product- or injection-related serious adverse events were reported. CONCLUSIONS: HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months. J Drugs Dermatol. 2024;23(4):255-261.     doi:10.36849/JDD.8145.

Understanding Public Awareness and Practices of Nonsurgical Facial Dermal Fillers: A Cross-Sectional Study in Saudi Arabia.

BACKGROUND: Dermal fillers augment soft tissues by replacing lost volume in the skin or subcutaneous fat. Dentists and other professionals utilize or recommend facial fillers for cosmetic and therapeutic purposes. AIMS: This study aims to investigate public awareness regarding using nonsurgical facial dermal fillers in Saudi Arabia. METHODS AND MATERIAL: A cross-sectional study was conducted using an online self-administered questionnaire distributed to a total of 400 males and females through social media platforms. The participants reside in Mecca, Saudi Arabia. Descriptive statistics and the Chi-square test were employed for data analysis. RESULTS: A total of 256 participants completed the survey, including 204 females and 51 males, with a mean age of 33.86 (SD = 10.5) years. Among the participants, 88 (34.4%) reported using facial fillers. Among them, only 46 (18%) were frequent consumers. Knowledge regarding correctly using facial fillers was generally high, especially for the lips (240, 94%), chin augmentation (203, 79.3%), and face lifting (226, 88.3%). However, participants' knowledge needed improvement in other areas. Most participants were aware of the side effects, except for visual impairment (83, 32.4%) and blockage of the vessels (128, 50%). CONCLUSIONS: The findings highlighted a remarkable level of knowledge among participants regarding the uses of fillers. However, participants demonstrated low awareness of all possible side effects associated with the treatment. Participants had valid reasons for undergoing facial treatments. However, constraints preventing them from pursuing fillers included fear of unexpected results and financial limitations.

The emerging topic of injected cosmetic fillers in the perinasal region of dromedary camels: ultrasonographic and radiographic verification.

Background: Dermal cosmetic fillers have been commonly used in camels in the last few years in Gulf countries. Aim: This study aimed to describe the radiographic as well as sonographic findings of injected cosmetic fillers in Arabian camel perinasal region in beauty shows. Methods: A total number of (n = 11,626) Arabian camels (Camelus dromedarius) were thoroughly investigated for injection of cosmetic fillers in the perinasal area. The age of the camels was 6 months to 10 years, and their weights were 400-650 kg. In parallel, a control group consisting of 30 age/weight-matched non-injected camels was used. Of the 11,626 examined camels, 25 animals (0.0.002%) were injected with cosmetic fillers in the perinasal region. Of the 25 camels, 19 (76%) were females and 6 (24%) were males. Radiographic examinations were carried out for the 25 injected camel perinasal regions. Results: Ultrasonographic examination of the injected perinasal regions revealed precise discrimination of the filler material, which appeared hypo-echogenic in 17 camels (68%) and with anechoic spots in the remaining 8 camels (32%). Variable degrees of swelling caused by the injection of moderate and large quantities of fillers were noted by radiographic assessment, the injected cosmetic filler was precisely diagnosed in the perinasal region as grey in color having soft tissue density in obtained radiographs. Conclusion: In conclusion, radiographic and ultrasonographic examinations are reliable, accurate, and non-invasive diagnostic imaging techniques that can precisely discriminate a filler agent in the soft tissues and determine the situ and size of cutaneous deposits in dromedary camels (C. dromedarius).

Tofacitinib for managing granuloma formation after dermal filler injection: three case reports and literature review.

BACKGROUND: Granuloma formation is an uncommon and persistent skin inflammatory condition caused by the injection of dermal fillers. The exact cause of this reaction is not well understood, but it may be associated with irritating components or abnormal immune function. Treating granulomas can be difficult. However, recent research has shown that Janus kinase (JAK) inhibitors hold promise as a potential therapy for refractory granulomatous diseases. OBJECTIVES: The aim was to evaluate the efficacy and safety of tofacitinib as a treatment for granulomas secondary to filler injection and the possible mechanisms were discussed and summarized. METHODS: This study focuses on three cases of patients who experienced granuloma formation after receiving filler injections and were subsequently treated with tofacitinib. The efficacy and safety of the treatment were evaluated using parameters such as photographs and monitoring for any adverse reactions. In addition, a literature review was conducted to explore the underlying mechanisms and potential effects of tofacitinib. RESULTS: All three cases recovered from swelling and nodules without side effects through the off-label use of oral tofacitinib. Existing data review reveals some approaches for cutaneous granulomatous disorders like inhibiting macrophage activation and downregulation of the JAK-STAT pathway. CONCLUSION: This report emphasizes the effectiveness of JAK inhibitors in treating granulomas caused by filler injections. Recent advancements in understanding the underlying mechanisms of granulomatous reactions have paved the way for JAK inhibitors to be regarded as a promising treatment choice. However, further research is necessary to fully assess the safety and long-term effectiveness of using tofacitinib for granuloma treatment.

Anatomy of the temporal region to guide filler injections.

Hollow temples are not typically considered aesthetically pleasing, and hollowness worsens with the aging process. When filling this region with fillers, there are several anatomical considerations, with injection techniques varying depending on the layer targeted. Specifically, injections between the superficial temporal fascia and the superficial layer of the deep temporal fascia are performed using a cannula, while periosteal layer injections involve the use of a needle to reach the bone before inserting fillers. Detailed anatomical insights encompass the boundaries of the temporal fossa and cautionary notes regarding blood vessels, supported by specific studies on veins and arteries in the temporal region. Complications, including vessel injuries, are discussed alongside an exploration of various injection techniques. This review provides a comprehensive exploration of anatomical considerations and the specific methodologies employed in temple augmentation with fillers.

Investigating the impact of added Profhilo mesogel to subcision versus subcision monotherapy in treating acne scars; a single-blinded, split-face randomized trial.

BACKGROUND: Acne scar is an inflammatory condition, which commonly occurs in patients with acne vulgaris, especially in adults. Mesogels have been reported effective in improving atrophic acne scars. AIMS: We investigated the efficacy of adding Profhilo (a hyaluronic acid-based filler) to subcision as a new treatment method. METHODS: Twelve patients aged 18-45 years with atrophic acne scars on both sides of the face participated in this single-blinded, split-face, randomized controlled trial. Each side of the face was randomly assigned to one of the treatment methods, including subcision alone and subcision + Profhilo. Patients in the Profhilo arm received mesogel (1 cc) in addition to the subcision procedure. Both methods were carried out two times at 1-month intervals. Assessments were done based on the sonographic depth of scars, and two blinded observers examined photographs at baseline and 3 months after the final session and the results were reported based on an exclusively made formula as the total score. The Global Improvement Scale and Visual Analogue Scale (VAS) (for patient satisfaction) were also used. RESULTS: The VAS score of patient satisfaction was statistically significant in the Profhilo arm, with a mean improvement of 528.08 and 219.06 in the subcision arm (p = 0.02). No significant difference was seen in total acne scar reduction comparing the two methods (29.74 in the Profhilo arm and 22.27 in the subcision arm, p = 0.56). Sonographic depth reduction was also non-significant, with a mean of 29.21 in the Profhilo arm and 28.53 in the subcision arm (p = 0.4). The mean global improvement was reported as four in both arms, and no statistical significance was observed (p = 0.89). The best response to treatment belonged to the rolling subtype in both methods (p = 0.029 for the Profhilo arm and p = 0.001 for the subcision arm). CONCLUSION: Despite no significant difference between the methods, Profhilo is more effective due to a higher satisfaction rate and better physiologic effects.

Revitalizing the lower face: Therapeutic insights and an innovative treatment guideline for jowl rejuvenation.

BACKGROUND: The intricate mechanisms of jowl formation, which ultimately lead to loss of lower jaw definition, skin laxity, and localized fat accumulation, involve interrelated factors such as skin aging, fat redistribution, muscle dynamics, and loss of support. AIMS: To propose a structured approach to the treatment of the jowl area that is comprehensive and tailored to the needs of each individual patient. MATERIALS AND METHODS: This integrative review combines a meticulous analysis of the literature with practical insights from real-world clinical settings. The authors draw on their extensive clinical experience to bridge research findings with practical clinical perspectives. RESULTS: This study presents a guideline for addressing jowl formation that starts with the major aging processes and, based on simple diagnostic questions, suggests minimally invasive interventions, including collagen stimulators, energy-based devices, lipolytic injectables, polydioxanone threads, and hyaluronic acid fillers. DISCUSSION: The guideline emphasizes the significance of personalized treatments while also acknowledging the need for comprehensive evaluation and recognizing the ever-evolving nature of aesthetic interventions in jowl management. CONCLUSION: This systematic approach can not only simplify diagnostic and treatment decisions for dermatologists but also enhance patient satisfaction by customizing treatment plans based on individual characteristics and expectations.

Restoring long-lasting midface volume in the Asian face with a hyaluronic acid filler: A randomized controlled multicenter study.

BACKGROUND: Hyaluronic acid (HA) filler treatment is a minimally-invasive alternative to surgery to volumize the cheeks. HAVOL (Restylane® Volyme) is a flexible HA filler suited to contouring and volumizing the midface. METHODS: This randomized, evaluator-blinded, no-treatment controlled study evaluated effectiveness and safety of HAVOL for correction of midface volume deficit and midface contour deficiency in Chinese subjects. In total 111 subjects were randomized to HAVOL and 37 to no treatment (control). The primary endpoint was response, on the blinded evaluator-assessed Medicis Midface Volume Scale (MMVS), at 6 months after last injection for the treatment group and 6 months after randomization for controls, where response was defined as ≥1-point improvement from baseline on both sides of the face. RESULTS: HAVOL was superior to no treatment at 6 months, meeting the primary objective: 76% versus 8% MMVS responders, a difference of 68% (CI: 55.7%-79.4%, p < 0.0001). These effects were sustained in 51% at 12 months after last injection. A majority (≥96%) had improved aesthetic appearance of midface fullness at Month 1 (using the Global Aesthetic Improvement Scale [GAIS]), effects which remained in ≥80% up to 12 months. Volume change captured by 3D photography increased after 1 month to 3.6 mL (close to the total injected volume of 3.4 mL), and remained stable through 12 months. Over 97% reported satisfaction with results after treatment with HAVOL. Additionally, HAVOL was well tolerated, with no unanticipated related adverse events. CONCLUSIONS: This study showed that HAVOL is effective and well tolerated for midface treatment in a Chinese population.

El reposicionamiento malar. Presentación de una técnica original: punto MM / Malar repositioning. Presentation of an original technique: point MM

El envejecimiento facial es una sinergia compleja de cambios texturales de la piel, hiper- o hipoactividad muscular, reabsorción del tejido graso y resorción ósea. El déficit de volumen resultante, la deflación y la posterior caída del tercio medio facial produce una cara menos atractiva y juvenil. Los procedimientos inyectables en región malar son cada vez más populares y solicitados por los pacientes. El conocimiento de la anatomía de la cara media es fundamental para el inyector. La comprensión de la irrigación facial puede ayudar a disminuir la exposición a la aparición de hematomas y complicaciones vasculares severas. Existen múltiples técnicas de inyección propuestas para el tercio medio, en este artículo presentamos una técnica original, simple, segura y eficaz con resultados satisfactorios y riesgo reducido

Facial aging is a complex synergy of textural skin changes, muscle hyperactivity, fat dysmorphism, bone resorption. The resulting volume deficit and deflation of the mid face produces a less attractive and youthful face. Injectable midface procedures are becoming increasingly popular and requested by patients. Knowledge of the anatomy of the midface is critical for the injector. Understanding the irrigation of the face can help decrease the risk of hematoma and severe vascular complications. There are multiple injection techniques proposed for the middle third, in this article we present a simple, safe and effective technique with satisfactory results and lower risk

Skin boosters: Definitions and varied classifications.

BACKGROUND: The concept of "skin boosters" has evolved, marking a shift from traditional uses of hyaluronic acid (HA) fillers primarily for augmenting skin volume to a more diverse application aimed at improving dermal conditions. Restylane Vital and other HA fillers have been repurposed to combat skin aging and wrinkles by delivering HA directly to the dermis. OBJECTIVES: This review aims to define the term "skin booster" and to discuss the various components that constitute skin boosters. It seeks to provide a comprehensive overview of the different ingredients used in skin boosters, their roles, and their impact on enhancing dermal conditions. METHODS: A comprehensive review was conducted, focusing on representative skin booster ingredients. The approach involved analyzing the different elements used in skin boosters and their specific roles in enhancing dermal improvement. RESULTS: The findings indicate that skin boosters, encompassing a range of ingredients, are effective in improving the condition of the skin's dermis. The review identifies key ingredients in skin boosters and their specific benefits, including hydration, elasticity improvement, and wrinkle reduction. CONCLUSIONS: Skin boosters represent a significant development in dermatological treatments, offering diverse benefits beyond traditional HA fillers. This review provides valuable insights into the constituents of skin boosters and their effectiveness, aiding readers in making informed decisions about these treatments. The potential of skin boosters in dermatological practice is considerable, warranting further research and application.

Causes and management of sight threatening complications of dermal filler injections: A review.

Injectable dermal fillers continue to increase in popularity in aesthetic medicine. Although rare, vision loss secondary to filler injections is a devastating complication associated with a poor visual prognosis. The mechanism for vision loss is thought to be related to retrograde embolization of the dermal filler from peripheral vessels in the face into the ophthalmic arterial system. Early recognition and prompt management are essential if vision is to be salvaged. The use of retrobulbar hyaluronidase is still contentious, however when administered by a specialist, this treatment gives the best chance at visual recovery and should be considered for all cases.

Chin Augmentation and Treatment of Chin Retrusion with a Flexible Hyaluronic Acid Filler in Asian Subjects: A Randomized, Controlled, Evaluator-Blinded Study.

BACKGROUND: Aesthetic improvement of the chin is increasingly requested by patients, including those of Chinese origin. METHODS: A randomized, evaluator-blinded, no-treatment controlled study evaluated the effectiveness and safety of a flexible hyaluronic acid (HA) filler, Restylane® DefyneTM (HADEF), in the correction of chin retrusion in a Chinese adult population over 12 months after treatment. On Day 1, subjects were randomized 3:1 into two groups, HADEF or delayed-treatment controls, and those in the HADEF group were administered treatment. An optional touch-up treatment was administered 1 month after treatment to obtain optimal chin augmentation. The initially untreated control group was offered delayed-treatment after 6 months (including 1-month touch-up). RESULTS: HADEF was superior to no-treatment in improving chin retrusion according to the blinded evaluator at 6 months [Galderma Chin Retrusion Scale (GCRS) responder rate (≥ 1-point improvement from baseline) of 81% vs. 5% for untreated controls; p < 0.001, meeting the primary effectiveness objective. A majority of subjects maintained improvement at 12 months (61% in the HADEF group). All subjects reported satisfaction with results at 6 months after treatment with HADEF and aesthetic improvement rates per the global aesthetic improvement scale (GAIS) were high for 12 months following treatment, with an acceptable safety profile. CONCLUSIONS: These results demonstrated HADEF to be effective and safe for the correction of mild-to-moderate chin retrusion in Chinese subjects, confirming findings previously observed in a western population. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A Cross-Sectional Survey on Pain Management in Dermal Filler Injections from Physicians' and Patients' Perspectives.

BACKGROUND: Hyaluronic acid (HA) dermal fillers injection is a common procedure in patients with cosmetic needs. Concomitant pain is a major complaint among patients undergoing HA filler injections. Relevant research is limited and there is no consensus on pain management of dermal filler injection. OBJECTIVES: To assist physicians in determining a more appropriate treatment approach, and to better provide treatment suggestions. METHODS: A nationwide (China) cross-sectional survey was conducted using questionnaires designed for physicians and patients, respectively. A total of 62 semi-structured questionnaires were administered to aesthetic physicians via face-to-face interview, whereas 123 online-based questionnaires were collected from patients who have ever undergone HA treatment. The collected questionnaire information was analyzed using descriptive statistics and content analysis. RESULTS: 42 (67.74%) physicians observed that over 50% of their patients were concerned about pain during injection. 101 (82.11%) of patients were concerned about impending pain ≥5 points (a total score is 10) before injection. For preferred pain relief modalities, 48 (77.42%) physicians would choose a hyaluronic acid dermal filler with lidocaine, and 82 (66.67%) patients would choose anesthetic-containing products. 59 (95.16%) physicians who injected lidocaine-containing hyaluronic acid found patients had a comfortable treatment experience. CONCLUSIONS: Pain management during hyaluronic acid dermal fillers injection is important from both perspectives of physicians and patients. This survey showed that compared with other analgesic methods, lidocaine-containing hyaluronic acid has offered a more satisfying experience. It also provides insights to physicians and patients in pain management. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Simplifying the injector's armamentarium: An international consensus regarding the use of gel science to differentiate hyaluronic acid fillers and guide treatment recommendations.

BACKGROUND: The Restylane portfolio of soft tissue fillers spans a wide range of indications, due in part to their complementary manufacturing technologies [non-animal stabilized hyaluronic acid (NASHA) and Optimal Balance Technology (OBT/XpresHAn)]. Using an array of products, injectors can achieve a holistic, natural looking effect for their patients. However, with a wide range of products it may be difficult to choose an optimal combination. AIM: Simplify and align global use recommendations for NASHA versus OBT products. METHODS: Two pre-meeting surveys were completed by 11 key opinion leaders with international representation, with the goal of collecting information regarding their current injection practices for various anatomical regions of the face (i.e., temporal region, forehead, tear trough, lateral zygoma, anteromedial cheek, nose, pyriform aperture, nasolabial fold, perioral area, lips, labiomental crease, marionette lines, chin, and jawline). The data collected from these surveys was subsequently discussed in a consensus group meeting involving 11 voting members and 3 nonvoting members. RESULTS: Top product recommendations were identified for each anatomical area, along with secondary and tertiary recommendations that can also be used under defined circumstances. Recommendations were provided based on a consideration of elements such as patient features (e.g., skin thickness, bone structure), the desired aesthetic outcome, experience of the injector, and the preferred injection technique. CONCLUSION: A majority consensus regarding the top NASHA versus OBT product choice for each anatomical region of the face was reached. These recommendations represent international agreement regarding the use of Restylane products.

Comparison of Hyaluronidase-Mediated Degradation Kinetics of Commercially Available Hyaluronic Acid Fillers In Vitro.

BACKGROUND: The ability to degrade hyaluronic acid (HA)-based fillers with hyaluronidase allows for better management of adverse effects and reversal of suboptimal treatment outcomes. OBJECTIVES: The aim of this study was to compare the enzymatic degradation kinetics of 16 commercially available HA-based fillers, representing 6 manufacturing technologies. METHODS: In this nonclinical study, a recently developed in vitro multidose hyaluronidase administration protocol was used to induce degradation of HA-based fillers, enabling real-time evaluation of viscoelastic properties under near-static conditions. Each filler was exposed to repeated doses of hyaluronidase at intervals of 5 minutes to reach the degradation threshold of G' ≤ 30 Pa. RESULTS: Noticeable differences in degradation characteristics were observed based on the design and technology of different filler classes. Vycross fillers were the most difficult to degrade and the Cohesive Polydensified Matrix filler was the least difficult to degrade. Preserved Network Technology products demonstrated proportional increases in gel degradation time and enzyme volume required for degradation across the individual resilient hyaluronic acid (RHA) products and indication categories. No obvious relationship was observed between gel degradation characteristics and the individual parameters of HA concentration, HA chain length, or the degree of modification of each filler when analyzed separately; however, a general correlation was identified with certain physicochemical properties. CONCLUSIONS: Manufacturing technology was the most important factor influencing the reversibility of an HA product. An understanding of the differential degradation profiles of commercially available fillers will allow clinicians to select products that offer a higher margin of safety due to their preferential reversibility.