Artigos científicos publicados
IMPACT OF COVID-19 ON MAXILLOFACIAL SURGERY PRACTICE: A SYSTEMATIC REVIEW. Luís Eduardo Charles Pagotto, Thiago de Santana Santos, Gabriel Pires Pastore. Brazilian Journal of Otorhinolaryngology. Volume 88, Issue 6, 2022, Pages 990-998, https://doi.org/10.1016/j.bjorl.2021.09.002.
Objectives: The aim of this systematic review was to evaluate the possible impacts of COVID-19 on oral and maxillofacial surgery practice, as well as the protocols employed by oral and maxillofacial surgeons to minimize the risks of contamination.
Methods: Searches were performed in different databases up to 15 March 2021. Articles related to oral surgery dynamics within the context of the COVID-19 pandemic were included. The articles were considered eligible if they met the following inclusion criteria: observational studies that provided recommendations regarding maxillofacial surgery measures during the COVID-19 pandemic and that analyzed the risk of contamination of patients/professionals with SARS-CoV-2.
Results: Seven studies met the inclusion criteria and were selected for the present systematic review. Demands for personal protective equipment increased significantly, with studies reporting the scarcity of fundamental equipment such as FFP2/N95 masks. Significant changes in the infrastructure of outpatient, surgical and inpatient units and in the care protocols themselves were observed.
Conclusion: The COVID-19 pandemic particularly affected the routine of oral and maxillofacial surgery residents. Several additional recommendations for surgical practice or for the surgical team were evaluated and discussed, such as performing primarily urgent and emergency surgeries, remote patient care and screening, postponing elective surgeries, and new teaching methods in oral and maxillofacial surgery residency programs. In addition, screening of patients and of the surgery team for COVID-19 is strongly recommended.
EFFECTIVENESS OF DISC REPOSITIONING AND SUTURING COMPARING OPEN-JOINT VERSUS ARTHROSCOPIC TECHNIQUES: A SYSTEMATIC REVIEW AND META-ANALYSIS. Thiago de Santana Santos, Luís Eduardo Charles Pagotto, Eduardo Nascimento, Luciano Rezende, Daniel Cassano, João Roberto Gonçalves. Oral Surgery Oral Medicine Oral Pathology Oral Radiology. Published: February 26 2021. DOI: https://doi.org/10.1016/j.oooo.2021.02.015
Objective: The aim of this study is to present a systematic review of the effectiveness of discopexy in managing internal derangement of the temporomandibular joint (TMJ).
Study Design: We searched MEDLINE® through PubMed, SCOPUS, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL) and grey literature been accessed through Google Scholar, Openthesis and hand-searching from inception to July 2020. Search strategy yielded 363 potentially relevant studies. After screening titles and abstracts, 41 full-text articles were assessed for eligibility and 7 studies were included in the meta-analysis.
Results: There was an overall decrease in VAS pain score of 4.59 cm (CI 95% 2.03 to 7.16; P < 0.001) during the follow-up time and an overall increase of 10 mm (CI 95% 6.93 to 13.01; P < 0.001) in mouth opening after TMJ surgeries with discopexy.
Conclusions: The available evidence showed an overall decrease in VAS pain score and an improvement in mouth opening after TMJ surgeries with discopexy. Changes in maximal interincisal opening were greater after arthroscopic disc repositioning compared to open-joint procedure.
THE EFFICACY OF MESENCHYMAL STEM CELLS IN REGENERATING STRUCTURES ASSOCIATED WITH THE TEMPOROMANDIBULAR JOINT: A SYSTEMATIC REVIEW. Luís Eduardo Charles Pagotto, Thiago de Santana Santos , Gabriel Pires Pastore. Archives of Oral Biology 125 (2021) 105104.
Objectives: The objective of this systematic review is to evaluate the role of mesenchymal stem cells in the regenerative treatment of temporomandibular joint resorption.
Design: Search strategies were performed in the following databases: PubMed/MEDLINE, EMBASE, Cochrane Collaboration Library, and Web of Science. Two independent reviewers selected the included articles using a two-phase process based on the eligibility criteria. The reviewers independently collected the required infor- mation from the included articles. The methodological quality of the selected studies was assessed individually.
Result: In accordance with the inclusion and exclusion criteria, 703 studies were found and 8 articles were included. Thus, six studies using animal models and two human studies were included in this systematic review.
Conclusion: Based on the data of our systematic review, the use of mesenchymal stem cells is a promising method for the repair and regeneration of temporomandibular joint components.
COMPLICATIONS ASSOCIATED WITH ORTHOGNATHIC SURGERY: A SYSTEMATIC REVIEW. Allana Barbosa Corrêa, Alick Brianne Ribeiro Silva, Fernando Matheus Santana Tunel, Marco Tulio Leandro Ribeiro, Brenda Cristina Teles Santos, João Victor de Oliveira, Sara Mariana Alves Ramos, Jainy Estefany Martins, João Victor de Almeida Góes Silva1, Eduarda Francyane Lima de Souza, Luís Eduardo Charles Pagotto and Thiago de Santana Santos. International Journal of Development Research. Vol. 10, Issue, 07, pp. 38452-38457, July, 2020 https://doi.org/10.37118/ijdr.19430.07.2020.
Orthognathic surgery aims to restore the balance between the face and the skull, favoring a significant improvement in masticatory, respiratory, phonetic and facial aesthetics. However, during and after the procedure, some complications can be observed in patients. The objective of this systematic review was to assess in the scientific literature the main complications associated with orthognathic surgery during the intra and postoperative period. A systematic literature review was performed using Science Direct, Embase, Cochrane Collaboration Library and PubMed/MEDLINE as databases. Studies related to complications of orthognathic surgery were selected. The search strategy provided a total of 3.262 studies. After screening by reading the titles and abstracts, 32 studies were considered potentially eligible and read in full by the evaluators. At the end of the analysis, nine articles met all the inclusion criteria and were included in this systematic review. Studies have shown that among the observed complications, neurological injuries were the most frequent, followed by the presence of hemorrhage during osteotomy, dental devitalization, bone fractures and infections.It is important to note that the psychological factor of patients must be taken into account, so that they feel satisfied with the aesthetics of their face after the surgery.
SURGICAL MANAGEMENT OF UNICYSTIC AMELOBLASTOMA: CONSERVATIVE OR RADICAL APPROACH: A SYSTEMATIC REVIEW. Thiago de Santana Santos, Luís Eduardo Charles Pagotto, Mateus Ferreira Nogueira, Pedro Eschner de Souza, Luanda Tissiani, 6Isla Ribeiro de Almeida, Manoel Olavo Valentim Fernandes de Castilho, Amanda Angelina de Sousa, Jordana Davi Rodrigues, Rafael Arantes Soares Reis, Lucas Mariz de Menezes Torres and Vítor Puga Santos. International Journal of Development Research. Vol. 10, Issue, 07, pp. 37640-37644, July, 2020 https://doi.org/10.37118/ijdr.19360.07.2020.
Unicystic ameloblastoma is a benign epithelial odontogenic neoplasm that represents about 5 to 15% of all intraosseous ameloblastomas, its biological behavior is related to its histopathological subtypes, with the mural variant being the most aggressive. The objective of this systematic review was to evaluate in the scientific literature the effectiveness of the conservative and radical surgical approach in the treatment of unicystic ameloblastomas. A systematic literature review was performed using the Science Direct, Embase, Cochrane Collaboration Library, and PubMed/MEDLINE databases. Studies related to conservative and radical surgical therapies for the treatment of unicystic ameloblastomas were selected. The search strategy provided a total of 791 studies. After screening by reading the titles and abstracts, 25 studies were considered potentially eligible and read in full by the evaluators. At the end of the analysis, five articles met all the inclusion criteria and were included in this systematic review. Studies have shown that a conservative surgical approach for the treatment of unicystic ameloblastoma is recommended only for the luminal and intra-luminal variants, and is not recommended for the mural subtype. However, in order to carry out a radical treatment, one must take into account the age and health conditions of the patient. Post-surgical clinical and radiographic monitoring is of fundamental importance for early detection of recurrence.
EFFECT OF LASER THERAPY IN PERIODONTAL SURGERIES: A SYSTEMATIC REVIEW. Alick Brianne Ribeiro Silva, Fernanda Maria Matos Aragão de Souza, José da Cruz Luna Neto, Liliane Maria Dantas Lira, Noemi de Oliveira Souto, Allana Barbosa Corrêa, Victor Sebastião da Trindade Alemida, Bruno Vieira Albernaz, Ana Gabriela Carvalho Rocha, Ana Cláudia Santos Gomes, Luís Eduardo Charles Pagotto and Thiago de Santana Santos. International Journal of Development Research. Vol. 10, Issue, 07, pp. 37573-37577, July, 2020 https://doi.org/10.37118/ijdr.19315.07.2020
Photodynamic therapy in periodontics is used to obtain antimicrobial effects and also to assist in the healing process by acting on tissue healing and regeneration after performing surgical procedures. The objective of this systematic review was to evaluate in the scientific literature the effectiveness of using laser therapy in the surgical approach of periodontal procedures. A systematic review of the literature was performed using the Scopus, Science Direct, Embase, Cochrane Collaboration Library, and PubMed/ MEDLINE databases. Studies on the use of laser therapy in periodontal surgical procedures were selected. The search strategy provided a total of 365 studies. After selection, ten articles met all the inclusion criteria and were included in this systematic review. Studies have shown that the use of laser therapy is an excellent approach to promote tissue repair, analgesia and antimicrobial activity in periodontal tissues. The use of LLLI associated with periodontal surgical treatment has proved to be promising and in the near future, new protocols are expected to emerge that can provide excellent treatments for patients who undergo periodontal surgery.
PIEZOELECTRIC VERSUS CONVENTIONAL TECHNIQUES FOR ORTHOGNATHIC SURGERY: SYSTEMATIC REVIEW AND META- ANALYSIS. Luis Eduardo Charles Pagotto; Thiago de Santana Santos; Sara Juliana de Abreu de Vasconcellos; Joanes Silva Santos; Paulo Ricardo Saquete Martins-Filho. Jornal of Cranio-Maxillo-Facial Surgery. June 30, 2017. Vol. 45, Issue 10, p1607-1613. DOI: http://dx.doi.org/10.1016/j.jcms.2017.06.011
Purpose: The purpose of this study is to perform a systematic review and meta-analysis on complications after orthognathic surgery comparing piezosurgery with conventional osteotomy.
Methods: We conducted this study according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We performed a systematic search to identify randomized (RCTs) and non-randomized controlled trials (nRCTs) from PubMed, Scopus, Science Direct, Lilacs, Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar and OpenThesis that compared piezoelectric osteotomy and conventional osteotomy in patients submitted to orthognathic surgery with regard to operative time, intraoperative blood loss, postoperative swelling, pain, and neurosensitivity. We used mean difference (MD) and risk difference (RD) with 95% confidence interval to pool individual results of continuous and dichotomous outcome data, respectively.
Results: Eight (3 RCTs and 5 nRCTs) studies were selected. No difference was observed in operative time between piezosurgery and conventional osteotomies. We found a decrease of intraoperative blood loss by using piezosurgery (MD -128 mL; P < 0.001). Our meta-analysis also yielded a pooled difference in severe blood loss of 35% (P = 0.008) favoring piezosurgery. We pooled individual results of studies evaluating the neurosensitivy based on clinical neurosensory testing. Our meta-analysis showed a pooled difference in severe nerve disturbance of 21% (P < 0.0001) favoring piezosurgery over conventional osteotomy. The test for subgroup differences (I2 = 26.6%) indicated that follow-up time may have an impact on neurosensory disturbance. We found differences between piezosurgery and conventional osteotomy at 3 months (RD 28%; P < 0.001) and 6 months (RD 15%; P = 0.001) after surgery. Due to a lack of sufficient studies, meta-analysis for pain and swelling was not performed.
Conclusion: Our meta-analysis suggests that piezosurgery has favorable effects on complications associated with orthognathic surgery, including a reduction in intraoperative blood loss and severe nerve disturbance.
ESTUDO CLÍNICO PATOLÓGICO RETROSPECTIVO DOS CASOS DE TUMORES ODONTOGÊNICOS DIGNÓSTICADOS NO SERVIÇO DE PATOLOGIA CIRÚRGICA DA FOUSP NO PERÍODO DE 1957 A 2012. Dissertação de Mestrado - Pagotto, Luis Eduardo Charles (Catálogo USP).
Os tumores odontogênicos formam um grupo complexo de lesões, de comportamento clínico variado e encontrado exclusivamente na região bucomaxilofacial. Originam-se a partir das células que normalmente teriam a função de formar o dente, processo esse denominado odontogênese, que tem seu início entre a sexta e a sétima semanas de vida intrauterina. O objetivo deste trabalho foi realizar um estudo clinicopatológico de tumores odontogênicos diagnosticados no Serviço de Patologia Cirúrgica da Faculdade de Oodontologia da Universidade de São Paulo de 1957 a 2012. Foram compilados das fichas de requisição de exames e/ou prontuários dados referentes ao sexo, idade no momento do diagnóstico, cor da pele (branca, negra, ou outras), sintomatologia, tamanho da lesão, duração, localização anatômica, aspectos radiográficos, diagnóstico clínico e histopatológico. Os casos diagnosticados como tumores odontogênicos foram revisados, por um examinador previamente calibrado, com o objetivo de reclassificação das lesões conforme proposição atual da Organização Mundial da Saúde em 2005. Todos os dados obtidos foram inseridos e tabulados no Microsoft Office Excel 2013 e analisados no software BioEstat 5.0. Medidas de frequência central e de dispersão foram obtidas e os resultados apresentados em forma de tabelas e gráficos. Na análise estatística, foi empregado o teste Z de duas proporções com nível de significância de 5%. No período compreendido de 01 de janeiro de 1957 a 31 de dezembro de 2012, foram diagnosticados 2.114 casos de tumores odontogênicos. Do total de casos diagnosticados, 75 casos foram retirados da análise, pois representavam a mesma lesão em diferentes momentos. Portanto, 2.039 casos de tumores odontogênicos foram incluídos e, após revisão dos casos e reclassificação diagnóstica dos tumores odontogênicos, os 2.039 casos foram agrupados em 16 tipos histológicos diferentes, entre os quais 2.029 (99,51%) eram benignos e 10 (0,49%) malignos. De uma maneira geral, os tumores odontogênicos afetam pacientes na segunda e terceira décadas de vida, sem predileção por sexo, apresentam-se menores do que 1cm de diâmetro e são diagnosticados, em média, 2 anos após seu surgimento. A maioria das lesões acometem a região posterior da mandíbula, com exceção do odontoma e tumor odontogênico adenomatóide, e apresentam aspecto radiográfico radiolúcido inespecífico, o que dificulta um diagnóstico preciso sem a avaliação anatomopatológica.
ECTOPIC TOOTH ANKYLOSED IN THE LATERAL BONE WALL OF THE MAXILLARY SINUS. Lilian Caldas Quirino, Luis Pagotto, Décio dos Santos Pinto, Fábio Daumas Nunes, Juliana Seo. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology. February 2014. Volume 117, Issue 2, Page e154. DOI: 10.1016/j.oooo.2013.12.023
Ectopic teeth erupting in the maxillary sinus are rarely reported. Woman, 38, demonstrated radiographic evidence of ectopic tooth in the right maxillary sinus that had been growing for 8 years. Radiographic examination showed a radiopaque mass linked to the lateral wall of the maxillary sinus in intimate contact with the third molar's root but causing no sinus pathology or obstruction. Surgical management via Caldwell-Luc access was performed under general anesthesia. The ectopic third molar with the calcified mass was easily removed from the bone wall with a chisel. Histopathological examination showed dental tissue fragment displaying mostly dentinal tissue, basophilic line adjacent to the root, bone tissue, and amorphous eosinophilic mineralized mass. The patient is being followed-up. The causes of eruption of a tooth into the maxillary sinus are unclear, but several hypotheses are offered in the literature, such as developmental disturbances (cleft palate), trauma, cyst, infection, genetic factors, and dense bone.
PROGRESSIVE CONDYLAR RESORPTION OF TEMPOROMANDIBULAR JOINT AFTER ORTHOGNATHIC SURGERY. Luis Eduardo Charles Pagotto. Journal of Oral and Maxillofacial Surgery. Volume 40, Issue 10, October 2011, Pages 1190. DOI: 10.1016/j.ijom.2011.07.555
The resorption of the temporomandibular joint (TMJ) can occur, among some clinical situations, after orthognathic surgery in specific patients. This pathology affects a group with common characteristics, female patients, carrying of Class II dentofacial deformity, that had temporomandibular joint dysfunction (TJD) previously to the orthodontic and surgical treatment and that were operated by means of bimaxillary osteotomy involving great mandibular advancements. It is imperative that this group of patients receives adequate cares, like the treatment of the TJD's symptoms before the orthodontic/surgical procedures and monitoring. The main goal in these cases is to prevent or at least to minimize this resorption, that is an instability that leads to the relapse of the deformity after orthodontic and surgical treatment. To review the literature about this issue and report a clinical case of progressive condylar resorption.
MONOSTOTIC FIBROUS DYSPLASIA OF THE MAXILLA: A REVIEW OF THE LITERATURE AND REPORT OF 2 CASES*. Luis Eduardo Charles Pagotto, et al. Brazilian Journal of Oral and Maxillofacial Surgery. V.9, n.2, p.23-32, abr./jun.2009
Fibrous dysplasia is a benign fibrous osseous lesion that may involve on or more bones of the skeleton, the maxilla being the facial bone most frequently involved. It is a sporadic condition that results form a post- zygotic mutation in the GNAS1 gene, a protein linked to the guanine nucleotide, α stimulant of polypeptide 1 activity. Its main histopathologic feature is the replacement of normal bone tissue and medullar tissue by fibrocellular tissue and immature bone. This paper presents two cases of monostotic fibrous dysplasia involving the maxilla and zygomatic bone, describing and discussing the clinical, radiological and histopa- thologic characterisitics, the differential diagnosis and treatment.
EPIDEMIOLOGY OF THE FACIAL FRACTURES AT THE HOSPITAL MUNICIPAL DE URGÊNCIAS DE GUARULHOS, BRAZIL. Luis Eduardo Charles Pagotto. Journal of Oral and Maxillofacial Surgery. Volume 38, Issue 5, May 2009, Pages 493. DOI: 10.1016/j.ijom.2009.03.346
Background and Objectives: The objective of this study was to update the epidemiology of 815 cases of facial fractures at the Hospital Municipal de Urgências de Guarulhos, Brazil.
Methods: In a retrospective evaluation from January 2006 to December 2008 we have treated 815 cases of facial fractures in our Oral and Maxillofacial Urgency Service. We have statistically analysed the cases in relation of aetiology, gender, age, classification and localisation of the fracture as soon as the treatment form.
Results: Out of 815 cases treated, 36% were due to interpersonal injury, 30% from car accidents, 14% from gunshots and 20% from domestic accidents including falls. 63% of patients were male and 47% female. The average age was 26.7 years of age. The most prevalent fractures were mandible fractures with 22.7% followed by nasal bone fractures, 20.4%; zygomatic fractures, 18.2%; middle third fractures (Le Fort I, Le Fort II, Le Fort III), 13.0%; dentoalveolar fractures, 11.9%, multiple associated fractures 7.2%, naso-orbital-ethmoid fractures, 2.7%, only orbital fractures, 2.4% and superior third fractures 1.5%. 83% of all fractures were surgically treated. 17% were treated with non-surgical approach.
Conclusion: Mandibular fractures and nasal bone fractures were the most prevalent fractures. Zygomatic fractures were the third most common fractures. Facial fractures were most common in male in our service. The main aetiologies were due interpersonal fights and car accidents, and most fractures were surgically treated. Our statistics is comparable with world statistics differing only in percentage of which type of fractures.
USE OF RESORBABLE PLATES AND SCREWS FIXATION FOR MAXILLARY ADVANCEMENT: AN INITIAL EXPERIENCE. P.B. Mariani, F.R Marques, L.E.C. Pagotto. Journal of Oral and Maxillofacial Surgery. Volume 36, Issue 11, November 2007, Pages 1019. DOI: 10.1016/j.ijom.2007.08.191
The use of polylatic implants for orthognathic surgery has growing in the beginning of the century. The major advantages of this use consist on the fact that there is no residual implant and the patient acceptance on this material. The disadvantages include the cost and the handling. Herein, we show the initial experience in our service using resorbable plates and screws for maxillary fixation in maxillary advancement in 21 cases. We observed the need of maxilo-mandibular fixation (MMF) in the immediate post-operative time, and the stability in the immediate post-operative time, 1 month and 3 months after surgery. The stability was objectively evaluated observing the occlusion in the post-operative time and subjectively, the maxillary movement during palpation and mastication. We observe 2 (9.5%) cases of maxillary instability that need MMF in the immediate pos-operative. The first case we observed great maxillary movement. We opted for 15 days of MMF. The second case we observe maxillary retrusion, put in MMF for 10 days. Both cases have a good follow-up in 30 and 90 days. Disadvantages cited are not major problems in choosing the resorbable plates for maxillary fixation. The resorbable plates and screws is a good choice for maxillary fixation.
SURGICALLY ASSISTED MAXILLARY EXPANSION: COMPARISON AND ANALYSIS OF THE RESULTS OF 2 SURGICAL TECHNIQUES. Luis Pagotto, et al. Journal of Oral and Maxillofacial Surgery. Volume 65, Issue 9, Supplement, Pages 43.e108–43.e109, September 2007
Statement of the Problem: Compare and analyze the results of the surgical techniques, simplified and Le Fort I “subtotal” that can be performed for the maxillary surgical expansion.
Materials and Methods: Both male and female patients were chosen, 12 male and 08 female, ranging from 20 and 36 years old, regardless of their race, that couldn’t submit only to the maxillary orthopedic and transversal expansion. All surgeries were performed under general anesthesia by the same practitioner. The simplified sur- gical technique was performed in 10 patients (group-A). The Le Fort I “subtotal” surgical technique was per- formed in the other 10 patients (group-B). Both patients from (group-A) and (group-B) had the Hyrax palate-split- ting appliance previously assembled. All the patients (group A and B) were submitted to the same palate splitting appliance activation, being 2 mm during the surgery and from the fourth say after surgery, and 1mm daily divided in two activations. The measures were taken with a caliper straight into the patient’s oral cavity, among the mesiolingual cusp of the upper right and left first molars before the surgery and immediately after the end of activation.
Results: (Group-A) – The maxillary transversal expan- sion planned was obtained in the 10 cases. The average of maxillary transversal expansion was 9.05 mm. The mean time for activating the palate-splitting appliance was 9.3 days. A complication was observed due to the palate splitting appliance breakage. (Group-B) – The maxillary transversal expansion planned was obtained in the 10 cases. The average of maxillary transversal expan- sion was 8.82 mm. The mean time for activating the palate-splitting appliance was 8.8 days. A complication was observed where the patient presented a hematoma in jugal region immediately after surgery.
THE USE OF POLYLACTIC IMPLANTS AND PLATES (DELTA SYSTEM - LEIBINGER) IN ORAL AND MAXILLOFACIAL TRAUMA: A PRELIMINARY REPORT. PB. Mariani, L.E.C. Pagotto, A.R.S. Colucci, L.C. Manganello-Souza. Journal of Oral and Maxillofacial Surgery.
Volume 34, Supplement 1, 2005, Pages 85. Abstracts of the 17th International Conference on Oral and Maxillofacial Surgery
The purpose of this study was to evaluate and report our initial expe- rience with a resorbable fixation system in maxillofacial trauma. The specific goals were to evaluate the stability, complications, advantages and disadvantages of the use of resorbable. From January 2004 to January 2005 we operated 15 cases of facial fractures including 4 children and 11 adults from 4 to 53 years of age. Children were treated with a single 1.7 mm plate. The adults fractures evolved were 4 blow-out orbital floor fractures, 5 zigomatic fractures, 2 LeFort II fracture. Blow- out fractures were treated with resorbable mesh for orbital floor reconstruction. Zigomatic fractures and LeFort II fractures were treated with fixation in two points with 2.2 mm resorbable plate. In adult cases we observed one case of post-operative diplopia in very high supra-version, and the patient opted for no new surgical intervention. In one case of LeFort II fracture we observed what we considered a high level of maxillary mobility and opted for 10 days of maxillo-mandibular immobilization with successful result. Resorbable plates and mashes bring a good result in maxillofacial trauma in selected cases. In children there were more advantages because of the facial growth that is not affected with the fixation. In adults we opted in used resorbale material in fractures with no or minimal muscle influence in the estability. The complications observed were no related with resorbable material. More patients, more and extensive follow-ups is needed.