Factors influencing the impact of randomized clinical trials on dental implants: A bibliometric analysis.

OBJECTIVE: To analyze bibliometrics, characteristics, and the risk of bias of randomized controlled trials (RCTs) on dental implants published in six high-impact factor journals and to identify factors contributing to citation number. MATERIALS AND METHODS: A systematic electronic search was conducted in four databases (PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials) to identify RCTs on dental implants published in six dental journals between 2016 and 2017. Twenty-five bibliometric variables and paper characteristics were extracted to evaluate their contribution to the citation count. Risk of bias analysis was performed using the RoB2 tool. Negative binomial regression was used to examine the effects of predictor variables on the Citation count. Significance level was set to 5%. RESULTS: A total of 150 RCTs included received a cumulative citation count of 3452 until July 2022. In the negative binomial regression analysis, open-access RCTs exhibited 60% more citations, and RCTs that presented statistical significance received 46% more citations. Conversely, first author affiliations from Africa, Asia and Oceania continents showed 49% fewer citations than publications from Europe. Regarding the risk of bias, 73.3% of the RCTs had some concerns, while 26% were deemed to have a high risk of bias. Only one RCT (0.07%) showed a low risk of bias. CONCLUSION: Within the limitation of the study, factors such as open access, statistically significant results, and country influence the number of citations received by the RCTs on dental implants.

Salivary glands are a target for SARS-CoV-2: a source for saliva contamination.

The ability of the new coronavirus SARS-CoV-2 to spread and contaminate is one of the determinants of the COVID-19 pandemic status. SARS-CoV-2 has been detected in saliva consistently, with similar sensitivity to that observed in nasopharyngeal swabs. We conducted ultrasound-guided postmortem biopsies in COVID-19 fatal cases. Samples of salivary glands (SGs; parotid, submandibular, and minor) were obtained. We analyzed samples using RT-qPCR, immunohistochemistry, electron microscopy, and histopathological analysis to identify SARS-CoV-2 and elucidate qualitative and quantitative viral profiles in salivary glands. The study included 13 female and 11 male patients, with a mean age of 53.12 years (range 8-83 years). RT-qPCR for SARS-CoV-2 was positive in 30 SG samples from 18 patients (60% of total SG samples and 75% of all cases). Ultrastructural analyses showed spherical 70-100 nm viral particles, consistent in size and shape with the Coronaviridae family, in the ductal lining cell cytoplasm, acinar cells, and ductal lumen of SGs. There was also degeneration of organelles in infected cells and the presence of a cluster of nucleocapsids, which suggests viral replication in SG cells. Qualitative histopathological analysis showed morphologic alterations in the duct lining epithelium characterized by cytoplasmic and nuclear vacuolization, as well as nuclear pleomorphism. Acinar cells showed degenerative changes of the zymogen granules and enlarged nuclei. Ductal epithelium and serous acinar cells showed intense expression of ACE2 and TMPRSS receptors. An anti-SARS-CoV-2 antibody was positive in 8 (53%) of the 15 tested cases in duct lining epithelial cells and acinar cells of major SGs. Only two minor salivary glands were positive for SARS-CoV-2 by immunohistochemistry. Salivary glands are a reservoir for SARS-CoV-2 and provide a pathophysiological background for studies that indicate the use of saliva as a diagnostic method for COVID-19 and highlight this biological fluid's role in spreading the disease. © 2021 The Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.

Selective outcome reporting in randomized clinical trials of dental implants.

AIM: Selective outcome reporting (SOR) is a type of bias that occurs when the primary outcome of a trial protocol is changed or omitted in the paper. The purpose of this study was to evaluate the prevalence of SOR in publications of randomized clinical trials (RCT) concerning dental implants. MATERIALS AND METHODS: Two reviewers independently screened protocols registered at ClinicalTrials.gov until February/2019. If the protocol met the eligibility criteria, the reviewers tried to identify the corresponding publication. Data extraction was carried out by the same reviewers. Primary and secondary outcomes were recorded for each trial and compared to outcomes previously described in protocols. RESULTS: A total of 49 protocols were included. SOR was identified in 27 (55.1%) trials. The major discrepancies were as follows: protocol-defined primary outcome omitted in the publication (n = 6, 12.2%), new primary outcome introduced (n = 8, 16.3%), discrepancy in the primary outcome time frame (n = 17, 34.7%) and new secondary outcome introduced (n = 31, 63.3%). SOR was significantly associated with industry funding (p = 0.04) and timing of registration (p = 0.04). CONCLUSIONS: Our results indicate a high rate of SOR in dental implants clinical trials. Use of registry data during the peer-review process may help decreasing SOR.

Conventional Drilling Versus Piezosurgery for Implant Site Preparation: A Meta-Analysis.

The aim of this study was to evaluate if the stability of dental implants varies between dental implants placed by piezosurgery compared with those placed by conventional drilling. An electronic search in MEDLINE, SCOPUS, and the Cochrane Library was undertaken until August 2016 and was supplemented by manual searches and by unpublished studies at OpenGray. Only randomized controlled clinical trials that reported implant site preparation with piezosurgery and with conventional drilling were considered eligible for inclusion in this review. Meta-analyses were performed to evaluate the impact of piezosurgery on implant stability. Of 456 references electronically retrieved, 3 were included in the qualitative analysis and quantitative synthesis. The pooled estimates suggest that there is no significant difference between piezosurgery and conventional drilling at baseline (weighted mean differences [WMD]: 2.20; 95% confidence interval [CI]: -5.09, 9.49; P = .55). At 90 days, the pooled estimates revealed a statistically significant difference (WMD: 3.63; 95% CI: 0.58, 6.67, P = .02) favoring piezosurgery. Implant stability may be slightly improved when osteotomy is performed by a piezoelectric device. More randomized controlled clinical trials are needed to confirm these findings.

Selective outcome reporting in randomized clinical trials using the third molar surgery model.

Selective outcome reporting (SOR) can threaten the validity of results found in clinical trials. Some studies in the literature have analyzed SOR in dentistry, but there is no study that has observed SOR in clinical trials in oral and maxillofacial surgery. Impacted third molar surgery is one of the most used models in clinical trials to study mainly analgesic and anti-inflammatory drug interventions. Our study aimed to evaluate the prevalence of SOR in publications employing the third molar extraction clinical trial model, and to verify whether there was an association between the statistical significance of outcomes and other characteristics that could lead to SOR. A systematic search was performed on the ClinicialTrials.gov platform for randomized clinical trial protocols, using the condition of third molar extraction. The corresponding published articles were sourced in PubMed, Scopus, and Embase databases, and compared with the registered protocols regarding the methodological data, in terms of: sample calculation, primary outcome identification, end-point periods, insertion of new outcomes in the publication, and results of outcomes. 358 protocol records were retrieved; 87 presented their corresponding articles. SOR was identified in 28.74% of the publications, and had a significant relationship with changes in the protocol, insertions of new outcomes, and discrepancies in the types of study. General risk of bias was found to be low. There were associations between SOR and the discrepancies in terms of the type of study, the choice of new outcome, and changes in the history of protocol records. The prevalence of SOR in clinical research using the third molar extraction surgery model is moderate. The quality of the scientific reporting of the results and, consequently, the certainty of evidence relating to the intervention tested can be overstated, increasing the chances of misinterpretation by health professionals.

Clinically relevant outcomes in dental clinical trials: challenges and proposals.

The impact of clinical trials on patient care depends on the outcomes that they evaluate. In Dentistry, many trials use outcomes that are important to clinicians, but not to the patients. Thus, the aim of the present manuscript is to present an overview of the limitations, challenges, and proposals on the use of clinically relevant outcomes (CRO) in dental trials. Clinically relevant outcomes are variables that directly measure how the patient feels, functions, or survives. Some CROs, such as tooth loss, implant failure, and restorations failure require many years to occur and the number of events is low. The adoption of these variables as primary outcomes results in challenges for the researchers, such as use of large sample sizes and long follow-up periods. Surrogate outcomes, such as biomarkers, radiographic measurements and indexes, are frequently used to replace CROs. However, they present many limitations, since the effect of the treatment on a surrogate does not necessarily reflect a change in the clinical outcome. Some proposals for the adoption of CROs are presented, such as the development of core outcome sets within each dental specialties and the organization of multi-center clinical trials.

Does Surgical Experience Influence Implant Survival Rate? A Systematic Review and Meta-Analysis.

PURPOSE: The aim of this study was to assess the evidence of a correlation between the expertise of surgeons and the survival rate of dental implants. MATERIALS AND METHODS: An electronic search in four databases (MEDLINE, EMBASE, SCOPUS, and the Cochrane Library) was performed for publications from their inception to May 2016 and was supplemented by manual searches. Prospective and retrospective cohorts were included if they met the following criteria: (1) the presence of an exposed group (inexperienced surgeons); and (2) the presence of a control group (experienced surgeons). Meta-analyses were performed to evaluate the effect of expertise on implant failure. RESULTS: Of 609 potentially eligible articles, 8 were included in the qualitative analysis and 6 in the quantitative synthesis. Two meta-analyses were performed for different definitions of experienced surgeons. In the first meta-analysis, which included four retrospective comparative studies that defined experienced professionals as specialists, the experience of the surgeon did not significantly affect the implant failure rate (P = .54), with an odds ratio (OR) of 1.24 (95% CI, 0.62-2.48). In the second meta-analysis, which included two retrospective studies that defined experienced surgeons as professionals that had placed more than 50 implants, the expertise of the surgeon did significantly affect the implant failure rates (P = .0005), with an OR of 2.18 (95% CI, 1.40-3.39). CONCLUSION: The data from the included publications suggest that surgical experience did not significantly affect implant failure when considering experience based on specialty but were significantly affected when considering experience based on the number of implants placed. Further standardized prospective studies with a control of confounding factors are needed to clarify the role of surgical expertise on implant survival rates.

Clinically relevant outcomes in dental clinical trials: challenges and proposals

Abstract The impact of clinical trials on patient care depends on the outcomes that they evaluate. In Dentistry, many trials use outcomes that are important to clinicians, but not to the patients. Thus, the aim of the present manuscript is to present an overview of the limitations, challenges, and proposals on the use of clinically relevant outcomes (CRO) in dental trials. Clinically relevant outcomes are variables that directly measure how the patient feels, functions, or survives. Some CROs, such as tooth loss, implant failure, and restorations failure require many years to occur and the number of events is low. The adoption of these variables as primary outcomes results in challenges for the researchers, such as use of large sample sizes and long follow-up periods. Surrogate outcomes, such as biomarkers, radiographic measurements and indexes, are frequently used to replace CROs. However, they present many limitations, since the effect of the treatment on a surrogate does not necessarily reflect a change in the clinical outcome. Some proposals for the adoption of CROs are presented, such as the development of core outcome sets within each dental specialties and the organization of multi-center clinical trials.

Comparison of two commercial dentifrices in the reduction of gingivitis and plaque: a pilot study / Comparação de dois dentífricos comerciais na redução da gengivite e da placa bacteriana: um ensaio clínico randomizado controlado

Objectives: Chlorhexidine (CHX) and triclosan are the most used chemical agents in dentistry. However, the combination of these products has never been tested. We hypothesize that the addition of CHX to a triclosan dentifrice formulation may offer additional benefits in the reduction of plaque and gingivitis. Thus, the aim of this study was to compare a commercial dentifrice containing 0.05% chlorhexidine and 0.3% triclosan, with conventional toothpaste containing 0.3% triclosan, in the treatment of gingivitis and plaque reduction. Material and Methods: Thirty volunteers were randomly assigned to receive a dentifrice containing 0.05% CHX and 0.3% triclosan (CHX/ triclosan group) or a dentifrice containing basically 0.3% triclosan (Triclosan group). Subjects received clinical evaluation such as gingival index (GI) and plaque index (PI) at baseline, 30 and 60 days. Results: After 60 days, both treatments led to a significant improvement in GI and PI. There was no significant difference between groups as regards change in GI and PI (p>0.05). Conclusion: The combination of 0.05% CHX with 0.3% triclosan did not offer further benefits to gingival inflammation and plaque control when compared with a dentifrice containing 0.3% triclosan. (AU)

Objetivos: Clorexidina e triclosan são os agentes químicos mais utilizados em odontologia. No entanto, a combinação desses produtos nunca foi testada. Nós levantamos a hipótese de que a adição de clorexidina a um dentifrício contendo triclosan pode oferecer benefícios adicionais na redução de placa e gengivite. Assim, o objetivo deste estudo foi comparar um dentífrico comercial contendo 0,05% de clorhexidina e 0,3% de triclosan, com creme dental convencional contendo 0,3% de triclosan, no tratamento de gengivite e redução da placa. Material e Métodos: trinta voluntários foram distribuídos aleatoriamente para receber um dentifrício contendo 0,05% de clorexidina e 0,3% de triclosan ou um dentifrício contendo basicamente 0,3% de triclosan. Os indivíduos receberam avaliação clínica de índice gengival (IG) e índice de placa (IP) nos tempos 0, 30 e 60 dias. Resultados: após 60 dias, ambos os tratamentos levaram a uma melhora significativa no IG e IP. Não houve diferença significativa entre os grupos no que se refere à mudança no IG e IP (p> 0,05). Conclusão: A combinação de 0,05% de Clorexidina com 0,3% de triclosan não ofereceu benefícios adicionais para a redução de inflamação gengival e o controle da placa quando comparado com um dentifrício contendo 0,3% de triclosan (AU)

Adverse effect of beta-tricalcium phosphate with zeta potential control in repairing critical defects in rats' calvaria / Efeito adverso do beta-fosfato tricálcico com controle de potencial zeta no reparo de defeitos críticos em calvária de ratos

To evaluate whether a new biphasic cement composed of calcium sulfate and beta tricalcium phosphate with zeta potential control could induce or lead to bone neoformation in critical defects. METHODS: A critical defect of diameter 8 mm was made in the calvaria of forty male Wistar rats. In the Test Group (n = 20), the defects were filled with cement. In the Control Group (n = 20), the defect was not filled and only coagulum was present. The animals were sacrificed 7, 14, 21 and 42 days after the operation. Calvaria specimens were subjected to microtomography and were then prepared for histological analysis. The analyses included morphological assessment on the histopathology of the repair; comparative morphometric evaluation of the area of formation of bone trabeculae between the groups; and histochemical staining by means of tartrate-resistant phosphatase (TRAP) in order to identify osteoclasts. RESULTS: Microtomographic images of the defects filled by the cement did not show any decrease in area over the course of postoperative evolution. In the Test Group, the material continued to present a foreign-body response until the last observational periods. Histomorphological analysis showed that there were more significant groupings of giant cells in the Test Group and greater maturity of neoformed bone in the Control Group. Exogenous material was also present. Histomorphometric analysis showed that in the Control Group, the total area of bone neoformation was significantly greater (p = 0.009) and grew progressively. The giant cells presented a positive reaction to TRAP but no osteoclasts were observed. CONCLUSION: The ceramic cement did not induce or lead to bone neoformation from the microtomographic or histological point of view.

Avaliar se um novo cimento bifásico composto por sulfato de cálcio e beta fosfato tricálcico com controle de potencial zeta poderia induzir ou conduzir a neoformação óssea em defeitos críticos. MÉTODOS: Foi feito um defeito crítico de 8 mm de diâmetro na calvária de 40 ratos Wistar machos. No grupo teste (n = 20) os defeitos foram preenchidos pelo cimento. No grupo controle (n = 20) os defeitos não foram preenchidos, permaneceu apenas o coágulo. Os animais sofreram eutanásia em 7, 14, 21 e 42 dias do pós-operatório. Espécimes da calvária foram microtomografados e posteriormente preparados para análise histológica. As análises incluíram a avaliação morfológica da histopatologia do reparo e a avaliação morfométrica da área de formação das trabéculas ósseas comparativamente entre os grupos e coloração histoquímica por meio da fosfatase tartrato-resistente (TRAP) para identificação de osteoclastos. RESULTADOS: As imagens microtomográficas dos defeitos preenchidos pelo cimento não apresentaram diminuição da área de acordo com a progressão dos períodos pós-operatórios. No grupo teste houve permanência do material e resposta corpo estranho até os últimos períodos de observação. A histomorfologia mostrou agrupamentos mais expressivos de células gigantes no grupo teste e osso neoformado mais maduro no grupo controle e comprovou a presença de material exógeno. Na histomorfometria, a área total de neoformação óssea foi significativamente maior (p = 0,009) e crescente no grupo controle. As células gigantes apresentaram expressão histoquímica positiva para TRAP e não foram observados osteoclatos. CONCLUSÃO: O cimento cerâmico não induziu ou conduziu a neoformação óssea sob o ponto de vista microtomográfico e histológico.

Esterilização de guias em resina acrílica por plasma de peróxido de hidrogênio: estudo dimensional linear / Hidrogen peroxide plasma sterilization of surgical acrylic stents: a linear dimensional study

Guias cirúrgicos confeccionados em resina acrílica são dispositivos importantes na transposição de planejamento cirúrgico no transoperatório. É obrigatório a todo dispositivo que entrará em contato direto com a ferida cirúrgica que esteja esterilizado para garantir padrões ideais de assepsia e antissepsia no campo operatório. Equipamentos que empregam o plasma de peróxido de hidrogênio para esterilização estão ganhando cada vez mais as centrais de esterilização dos hospitais. Propusemo-nos a verificar, preliminarmente, em um estudo in vitro, se corpos de prova em resina acrílica em formato similar a guias cirúrgicos odontológicos podem sofrer alteração dimensional linear após processo de esterilização por plasma de peróxido de hidrogênio. 45 corpos de prova foram confeccionados em resina acrílica em três espessuras: 1.5mm, 3.0mm e 5.0mm. Foram submetidos à esterilização por plasma de peróxido de hidrogênio por igual período de tempo e temperatura. Imagens dos corpos de prova antes e após o processo foram obtidas digitalmente e formatadas por meio de um programa de computador que permitiu analisar alterações lineares. Os resultados mostraram que apenas os dispositivos de 1.5mm não sofreram alterações lineares estatisticamente significativas. Nos dispositivos acrílicos mais espessos, as alterações foram mais significativas. Estudos tridimensionais são necessários para verificar se essas interferências podem ter importância clínica.

Resin surgical stent is an important device to transfer pre surgical planning to the operative moment of a dental implant or an orthognatic surgery. To guarantee asepsis and anti sepsis, it is undeniable that, this critical material has to be sterile once it will be directly in contact with surgical wound. Since the nineties, hydrogen peroxide plasma sterilization equipments have gaining hospital centers for sterilization of materials that are sensible to heat but literature is rare about testing the performance of those devices after that sterilization process. The aim of this preliminary in vitro study is to verify if acrylic specimens shaped as dental stents undergo linear dimensions changes after peroxide hydrogen plasma sterilization process. 45 acrylic specimens were made in three different thicknesses: 1.5mm, 3.0mm and 5.0 mm. Specimens underwent sterilization employing peroxide hydrogen plasma for equal time and temperature. Digital images were kept from the specimens before and after the sterilization process and were analyzed by digital software comparing three linear dimensions in each specimen. The results showed that only 1.5mm specimens did not underwent significant linear extent changes. Tridimensional studies are necessary to conclude that those interferences are clinically important.

Antibioticoterapia como coadjuvante no tratamento periodontal não cirúrgico de pacientes diabéticos / Antibiotic therapy as an adjunct to non-surgical periodontal treatment in diabetic patients ­ a literature review

Objetivo: verificar se o uso de antibióticos sistêmicos, adjunto à terapia periodontal não cirúrgica, em pacientes diabéticos pode trazer benefícios adicionais no controle glicêmico e parâmetros clínicos periodontais. Material e métodos: após a busca nos bancos de dados PubMed e Lilacs, foram incluídos nove ensaios clínicos randomizados para essa revisão da literatura. Resultados: nos desfechos periodontais, seis dos nove ensaios clínicos encontraram algum benefício a favor da antibioticoterapia. Quanto ao controle glicêmico, a maioria dos estudos falhou ao tentar relacionar o uso de antibióticos a uma maior redução da hemoglobina glicada. Conclusão: com base nesta revisão, concluiu-se que o uso de antibióticos sistêmicos em conjunto com o tratamento periodontal não cirúrgico pode oferecer benefícios adicionais, quando comparado ao tratamento periodontal sozinho, no tratamento da periodontite em pacientes com diabetes. Não há evidências de que a antibioticoterapia possa contribuir no controle glicêmico desses pacientes, sendo necessários mais estudos clínicos.

Objective: to verify whether systemic antibiotic therapy along with non-surgical periodontal management in diabetic patients can bring additional benefi ts on the glycemic control and periodontal parameters. Material and methods: after an electronic search on Medline and Lilacs databases, 9 RCTs were included. Results: six articles found favorable outcomes for periodontal clinical parameters. Regarding the glycemic control, most studies failed to prove a relationship between antibiotic use and the reduction on glycated hemoglobin levels. Conclusion: within the limits of this review, it can be concluded that systemic antibioticotherapy added to non-surgical periodontal treatment can bring additional benefits when compared to non-surgical treatment alone for diabetes-affected periodontal patients. However, there is no evidence that antibiotics can contribute to the glycemic control and more studies are necessary on this subject.

O efeito da sinvastatina na osseointegração / The effect of simvastatin on osseointegration ­ a literature review

O crescente aumento de instalações de implantes dentais com carga imediata e de suas fixações em tecido ósseo de baixa densidade tem gerado a necessidade real de aceleração e aprimoramento do processo de osseointegração, e muitos métodos e técnicas têm sido propostos para solucionar este problema. Neste contexto, a presente revisão teve por objetivo discutir os principais aspectos do papel da sinvastatina como intervenção para a melhoria no processo de osseointegração. Os resultados indicaram que a sinvastatina apresentou efeitos positivos em estudos experimentais, sendo necessários ensaios clínicos randomizados.

With increasing applications of dental implants with immediate loading and their installation in low quality bone, there is a real need to speed up and improve the osseointegration process. This review aimed to discuss the use of simvastatin in improving the osseointegration. The results indicate that simvastatin showed positive results in experimental studies, although randomized clinical trials are necessary.

Avaliação radiográfica e histológica comparativa entre uma nova membrana eletrofiada de PCL/poli(rotaxona) e uma membrana de colágeno suíno na regeneração óssea guiada de defeito crítico em calvária de ratos Wistar / Radiographic and histological evaluation between a new electrospinning PCL/polyrotaxane membrane and a porcine collagen membranes in a guided bone regeneration model in Wistar rat's critical sized calvaria defects

Dentre as diversas possibilidades de reconstrução de tecidos ósseos atróficos, a regeneração óssea guiada é uma das mais promissoras. Neste contexto, muitas membranas reabsorvíveis tem sido desenvolvidas e precisam ser testadas como parte de sua caracterização. O objetivo do presente estudo foi avaliar radiográfica e histologicamente em um estudo in vivo, se uma nova membrana polimérica eletrofiada de PCL/poli(rotaxona) demonstra comportamento semelhante a uma membrana de colágeno, comercialmente consagrada, quanto à promoção de regeneração óssea guiada. Foi realizado defeito crítico de 8mm de diâmetro na calvária de 60 ratos Wistar machos. Em dois grupos iguais (n=20) os defeitos foram recobertos aleatoriamente por uma membrana de colágeno suíno ou por uma membrana polimérica mista de policaprolactona (PCL) e poli(rotaxona). Em um terceiro grupo (n=20) os defeitos não foram recobertos e permaneceram apenas com o coágulo. Os animais sofreram eutanásia em 7, 14, 21 e 42 dias pós operatórios. Espécimes da região foram radiografadas e preparadas para análise histológica. Radiograficamente, os defeitos recobertos pela membrana de colágeno suíno apresentaram diminuição mais significativa da área radiográfica dos defeitos de acordo com a progressão dos períodos pós-operatórios do que nos outros grupos. A histomorfologia do reparo mostrou agrupamentos mais expressivos de células gigantes no grupo PCL/poli(rotaxona) sugerindo resposta à corpo estranho. Na histomorfometria, a neoformação óssea foi significativamente mais intensa e com osso neoformado mais maduro no grupo Colágeno. Concluímos que para um modelo de regeneração óssea guiada, a membrana de PCL/poli(rotaxona) não superou a membrana de colágeno.

The need to rebuild lost bone tissue, shows up as one of the great challenges of modern dentistry. Among several possibilities, guided bone regeneration is one of the most established techniques. In this context, many resorbable membranes have been developed and need to be tested as part of their characterization. The aim of this study was to evaluate by an in vivo model, if a new electrospinning PCL/polyrotaxane polymer membrane promotes similar guided bone regeneration when compared to a collagen membrane. An 8mm diameter critical defect was made in 60 male Wistar rats calvaria. In two equal groups (n = 20) the defects were randomly covered with a porcine collagen or a PCL/polyrotaxane membranes. In a third group (n = 20) the defects remained uncovered and just the blood clot occupied the defect. The animals were euthanized at 7, 14, 21 and 42 days post-operative. Specimens were x-rayed and prepared for histological analysis. Radiographically, the defects covered by porcine collagen membrane, showed more significant reduction in defect area, according to postoperative period evolution. Histomorphology showed intense giant cells presence in the PCL/polyrotaxane group, suggesting a foreign body response. The histomorphometric analysis showed new and mature bone formation more intense in collagen group. Under the limits of this study, the collagen membrane performance in guided tissue regeneration was far superior to the PCL/polyrotaxane membrane.

A rhBMP-2 aumenta e acelera a formação óssea vertical quando associada a biomateriais em calvária de coelhos / rhBMP-2 increases and accelerates vertical bone formation when associated to biomaterials: the rabbit calvaria model

O objetivo deste estudo foi avaliar a formação óssea vertical aposicional obtida com a associação da proteína morfogenética óssea recombinante humana 2 (rhBMP-2) com os materiais beta fosfato tricálcico (CE), fosfato de cálcio bifásico (BC) e osso mineral bovino (BO) em um modelo de regeneração óssea guiada (ROG) em calvária de coelhos; 22 coelhos albinos da raça Nova Zelândia receberam quatro cilindros de titânio fixados na calvária. No grupo 1 (n = 10), os cilindros foram aleatoriamente preenchidos com um dos referidos materiais e coágulo sanguíneo (CO). No grupo 2 (n = 12), foi repetida a mesma distribuição aleatória dos materiais e coágulo, acrescidos da rhBMP-2. Corantes ósseos foram aplicados durante 13 semanas e a eutanásia foi realizada na 14a semana nos dois grupos. Os resultados clínicos mostraram que o volume ósseo e a sua área média no grupo 2 (com rhBMP-2) foram maiores do que no grupo 1 (sem rhBMP-2), independente dos materiais utilizados (p < 0,001). Não houve diferença estatisticamente significante entre os volumes médios de BC e BO (p = 0,625), BC e CE (p = 0,876), BO e CE (p = 0,968). O volume médio do CO foi menor do que todos os materiais (p < 0,001) nos dois grupos. Não houve diferença significativa entre as médias das áreas em BC e BO (p = 0,965), BC e CE (p = 0,866), BO e CE (p = 0,990), BC e CO (p = 0,190), BO e CO (p = 0,060). A área média do CO foi menor em CE (p = 0,028). O estudo histológico revelou quantidades significativas de tecido ósseo neoformado nos dois grupos. No entanto, no grupo com rhBMP-2, foi observado osso mais maduro e lamelar, e com maior taxa de biodegradação em todos os materiais. A análise de fluorescência mostrou que a adição de rhBMP-2 é mais significativa na porção superior do cilindro e que a formação óssea é tempo-dependente. Pôde-se concluir que a utilização da rhBMP-2 associada a qualquer um dos biomateriais gerou maior formação óssea neste modelo de regeneração óssea guiada (ROG) em coelhos.

The aim of this study was to evaluate the appositional vertical bone formation obtained with the association of recombinant human bone morphogenetic protein 2 (rhBMP-2) with the materials Beta Tricalcium Phosphate (CE), Biphasic Calcium Phosphate (BC), and Mineral Bovine Bone (BO) in a guided bone regeneration model (GBR) in rabbit calvaria. Twenty-two New Zealand white rabbits received four titanium cylinders fixed in the calvaria. In group 1 (n = 10), each cylinder was randomly filled with one of these materials and one with a blood clot (CO). In group 2 (n = 12) cylinders were randomly assigned the same materials and blood clot with the addition of rhBMP-2. Bone labels were injected during 13 weeks, and the euthanasia was performed in the 14th week in both groups. The results showed that the average volume and area in group 2 (with rhBMP-2) was higher than that in group 1 (without rhBMP-2), regardless the materials used (p < 0.001). There was no statistically significant difference between the average volumes of BO and BC (p = 0.625), BC and CE (p = 0.876) and BO and CE (p = 0.968). The average volume of CO was lower than all materials (P < 0.001) in both groups. There was no statistically significant difference between the average areas of BC and BO (p = 0,965), BC and CE (p = 0,866), BO and CE (p = 0,990), BC and CO (p = 0,190) and BO and CO (p = 0,060). The average area of CO was lower than CE (p = 0,028). The histological study revealed significant amounts of newly formed bone in both groups. Nevertheless, in the group with rhBMP-2 a more mature and lamellar bone with a greater level of biodegradation in all materials was observed. The fluorescence analysis showed that the addition of rhBMP-2 is more significant in the upper portion of the cylinder and that bone formation is time-dependent...

A rhBMP-2 aumenta e acelera a formação óssea vertical quando associada a biomateriais em calvária de coelhos / rhBMP-2 increases and accelerates vertical bone formation when associated to biomaterials: the rabbit calvaria model

O objetivo deste estudo foi avaliar a formação óssea vertical aposicional obtida com a associação da proteína morfogenética óssea recombinante humana 2 (rhBMP-2) com os materiais beta fosfato tricálcico (CE), fosfato de cálcio bifásico (BC) e osso mineral bovino (BO) em um modelo de regeneração óssea guiada (ROG) em calvária de coelhos; 22 coelhos albinos da raça Nova Zelândia receberam quatro cilindros de titânio fixados na calvária. No grupo 1 (n = 10), os cilindros foram aleatoriamente preenchidos com um dos referidos materiais e coágulo sanguíneo (CO). No grupo 2 (n = 12), foi repetida a mesma distribuição aleatória dos materiais e coágulo, acrescidos da rhBMP-2. Corantes ósseos foram aplicados durante 13 semanas, e a eutanásia foi realizada na 14a semana nos dois grupos. Os resultados clínicos mostraram que o volume ósseo e a sua área média no grupo 2 (com rhBMP-2) foram maiores do que no grupo 1 (sem rhBMP-2), independente dos materiais utilizados (p < 0,001). Não houve diferença estatisticamente significante entre os volumes médios de BC e BO (p = 0,625), BC e CE (p = 0,876), BO e CE (p = 0,968). O volume médio do CO foi menor do que todos os materiais (p < 0,001) nos dois grupos. Não houve diferença significativa entre as médias das áreas em BC e BO (p = 0,965), BC e CE (p = 0,866), BO e CE (p = 0,990), BC e CO (p = 0,190), BO e CO (p = 0,060). A área média do CO foi menor em CE (p = 0,028). O estudo histológico revelou quantidades significativas de tecido ósseo neoformado nos dois grupos. No entanto, no grupo com rhBMP-2, foi observado osso mais maduro e lamelar, e com maior taxa de biodegradação em todos os materiais. A análise de fluorescência mostrou que a adição de rhBMP-2 é mais significativa na porção superior do cilindro e que a formação óssea é tempo-dependente. Pôde-se concluir que a utilização da rhBMP-2 associada a qualquer um dos biomateriais gerou maior formação óssea neste modelo de regeneração óssea guiada (ROG) em coelhos.

The aim of this study was to evaluate the appositional vertical bone formation obtained with the association of recombinant human bone morphogenetic protein 2 (rhBMP-2) with the materials Beta Tricalcium Phosphate (CE), Biphasic Calcium Phosphate (BC), and Mineral Bovine Bone (BO) in a guided bone regeneration model (GBR) in rabbit calvaria. Twenty-two New Zealand white rabbits received four titanium cylinders fixed in the calvaria. In group 1 (n = 10), each cylinder was randomly filled with one of these materials and one with a blood clot (CO). In group 2 (n = 12) cylinders were randomly assigned the same materials and blood clot with the addition of rhBMP-2. Bone labels were injected during 13 weeks, and the euthanasia was performed in the 14th week in both groups. The results showed that the average volume and area in group 2 (with rhBMP-2) was higher than that in group 1 (without rhBMP-2), regardless the materials used (p < 0.001). There was no statistically significant difference between the average volumes of BO and BC (p = 0.625), BC and CE (p = 0.876) and BO and CE (p = 0.968). The average volume of CO was lower than all materials (P < 0.001) in both groups. There was no statistically significant difference between the average areas of BC and BO (p = 0,965), BC and CE (p = 0,866), BO and CE (p = 0,990), BC and CO (p = 0,190) and BO and CO (p = 0,060). The average area of CO was lower than CE (p = 0,028). The histological study revealed significant amounts of newly formed bone in both groups. Nevertheless, in the group with rhBMP-2 a more mature and lamellar bone with a greater level of biodegradation in all materials was observed...