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.

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.

Selective outcome reporting bias is highly prevalent in randomized clinical trials of nonsurgical periodontal therapy.

Selective outcome reporting (SOR) is a type of bias that can compromise the validity of results and affect evidence-based practice. SOR can overestimate the effect of an intervention and lead to conclusions that a treatment is effective when it is not. This study aimed to investigate the prevalence of SOR in publications of RCTs on nonsurgical periodontal therapy (NSPT) and to verify associated factors. The protocols were searched and selected on the www.clinicaltrials.gov platform up to January 16, 2022. Corresponding publications were identified, and data extraction and discrepancy analysis were performed. The risk of bias was assessed according to the RoB2 tool. One hundred forty-five studies (174 publications) were included. The prevalence of SOR was 49.7% and was unclear in nearly one third of studies (27.6%). Only 31.7% of the primary outcomes were completely described in the publications. The overall risk of bias was high in 60% of the included studies. SOR was associated with statistical significance (p < .001), and multiple publications of the same study (p = .005). Our study demonstrated the high prevalence of SOR, highlighting the need to improve the quality of reporting of RCTs on NSPT studies.

Risk of Bleeding during Implant Surgery in Patients Taking Antithrombotics: A Systematic Review.

The objective of this systematic review is to assess the risk of postoperative bleeding in oral surgery for implant placement in individuals taking antithrombotics (i.e., anticoagulants and/or antiplatelet agents). A literature search was performed in PubMed (MEDLINE), Web of Science, Scopus, and EMBASE databases for articles published until August 2020, with no date restriction, and manually completed. We included prospective clinical studies that provided information regarding the presence of an experimental group (i.e., implant placement), a control group (patients not under treatment with antithrombotics), and a well-established protocol for evaluating bleeding. Meta-analysis determined the risk of bleeding during the placement of implants in antithrombotic-treated patients. Of the 756 potentially eligible articles, 5 were included in the analysis with 4 ranked as high and 1 as medium quality. Antithrombotic treatment comprised the following drug classes: (1) anticoagulants: vitamin K antagonists, (2) nonvitamin K antagonist oral anticoagulants, (3) low-molecular-weight heparin, and (4) antiplatelet agents (not specified). The results suggest that the risk of bleeding is not substantially higher in antithrombotic-treated patients (odds ratio = 2.19; 95% confidence interval: 0.88-5.44, p = 0.09) compared with nontreated patients. This systematic review suggests that the absolute risk is low and there is no need to discontinue or alter the dose of the antithrombotic treatment for implant placement surgery.

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 root coverage randomized clinical trials.

BACKGROUND: Outcome discrepancies between protocols and respective publications represent a concerning bias. The purpose of this study was to assess the prevalence of selective outcome reporting (SOR) in root coverage randomized clinical trials (RCTs). METHODS: Published root coverage RCTs (July 2005 to March 2020) were included if a corresponding protocol could be identified in a public registry. Discrepancies between protocol and its correspondent publication(s) were compared regarding primary and secondary outcomes and other study characteristics. Associations between trial characteristics and SOR were evaluated. RESULTS: Forty four studies (54 publications) were included. The majority of studies (77.3%) were retrospectively registered. SOR was frequent (40.9% of trials) and consisted of primary outcome downgrade (22.7%); secondary outcome upgrade (11.4%); new primary outcome introduced in publication (25%); protocol primary outcome omitted from publication (13.6%) and discrepancy in primary outcome timing (18.2%). SOR was unclear in 20.5% of studies and favoured statistical significance in 12 studies (27.3%). SOR was significantly associated with study significance (p < 0.001) and unclear outcome definition in the publication (p < 0.001). Only a third (32.8%) of primary outcomes were completely defined. CONCLUSIONS: The present study identified high prevalence of SOR in root coverage RCTs.

Salivary glands are a target for SARS-CoV-2: a source for salivacontamination

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 innasopharyngeal swabs. We conducted ultrasound-guided postmortem biopsies in COVID-19 fatal cases. Samples ofsalivary glands (SGs; parotid, submandibular, and minor) were obtained. We analyzed samples using RT-qPCR, immu-nohistochemistry, electron microscopy, and histopathological analysis to identify SARS-CoV-2 and elucidate qual-itative and quantitative viral proles in salivary glands. The study included 13 female and 11 male patients, with amean age of 53.12 years (range 8­83 years). RT-qPCR for SARS-CoV-2 was positive in 30 SG samples from18 patients (60% of total SG samples and 75% of all cases). Ultrastructural analyses showed spherical 70­100 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 acluster of nucleocapsids, which suggests viral replication in SG cells. Qualitative histopathological analysis showedmorphologic alterations in the duct lining epithelium characterized by cytoplasmic and nuclear vacuolization, as wellas 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 cellsof major SGs. Only two minor salivary glands were positive for SARS-CoV-2 by immunohistochemistry. Salivaryglands are a reservoir for SARS-CoV-2 and provide a pathophysiological background for studies that indicate theuse of saliva as a diagnostic method for COVID-19 and highlight this biological uid's role in spreading the disease.© 2021 The Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.

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.

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.

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.

Growth Dynamic of Allogeneic and Autogenous Bone Grafts in a Vertical Model.

Several techniques have been proposed for vertical bone regeneration, and many of them use bone autogenous and allogeneic grafts. The purpose of this study was to compare demineralised freeze-dried bone allografts (DFDBA), fresh-frozen (FF) allografts, autogenous bone grafts to find differences between volumetric and histological quantity of bone formation and vertical bone growth dynamic. A vertical tissue regeneration bone model was performed in rabbit calvarias under general anaesthesia. Four hollow cylinders of pure titanium were screwed onto external cortical bone calvarias in eight rabbits. Each one of the cylinders was randomly filled with one intervention: DFDBA, FF, autogenous bone, or left to be filled with blood clot (BC) as control. Allogeneic grafts were obtained from a ninth animal following international standardised protocols for the harvesting, processing, and cryopreservation of allografts. Autogenous graft was obtained from the host femur scraping before adapting hollow cylinders. Animals were euthanized at 13 weeks. Vertical volume was calculated after probe device measurements of the new formed tissue inside the cylinders and after titanium cylinders were removed. Histomorphometry and fluorochrome staining were used to analyse quantity and dynamic of bone formation, respectively. Results showed that DFDBA and fresh-frozen bone improved the velocity and the quantity of bone deposition in distant portions of the basal plane of grafting. Remaining material in allograft groups was more intense than in autogenous group. Both allografts can be indicated as reliable alternatives for volume gain and vertical bone augmentation.

Is conservative surgery a better choice for the solid/multicystic ameloblastoma than radical surgery regarding recurrence? A systematic review.

PURPOSE: Determine if conservative surgery of primary solid/multicystic ameloblastoma (SMA) is capable of decreasing the recurrence rate as effectively as radical surgery. METHODS: We searched in MEDLINE, Web of Science, Scopus and Cochrane Library for original studies reporting on the conservative or radical treatment of primary SMA and the related recurrence rate. All selected data were independently assessed. Meta-analysis was performed and the Relative Risk (RR) of recurrence with a confidence interval of 95% was the effect measure. P value for the summary effect of < 0.05 was considered statistically significant. RESULTS: The 2647 records retrieved were reduced to 7 studies to be qualitatively assessed and 4 studies were included in the meta-analysis. RR of 1.88 [0.59, 5.95] of the pooled values pointed that recurrence rate after the conservative surgery is neither comparable nor lower than the radical surgery (P = 0.28). CONCLUSIONS: Conservative surgery does not reduce the recurrence rate as efficiently as radical surgery for primary SMA. However, there is not enough evidence to support this statement.

Growth dynamic of allogeneic and autogenous bone grafts in a vertical model

Abstract Several techniques have been proposed for vertical bone regeneration, and many of them use bone autogenous and allogeneic grafts. The purpose of this study was to compare demineralised freeze-dried bone allografts (DFDBA), fresh-frozen (FF) allografts, autogenous bone grafts to find differences between volumetric and histological quantity of bone formation and vertical bone growth dynamic. A vertical tissue regeneration bone model was performed in rabbit calvarias under general anaesthesia. Four hollow cylinders of pure titanium were screwed onto external cortical bone calvarias in eight rabbits. Each one of the cylinders was randomly filled with one intervention: DFDBA, FF, autogenous bone, or left to be filled with blood clot (BC) as control. Allogeneic grafts were obtained from a ninth animal following international standardised protocols for the harvesting, processing, and cryopreservation of allografts. Autogenous graft was obtained from the host femur scraping before adapting hollow cylinders. Animals were euthanized at 13 weeks. Vertical volume was calculated after probe device measurements of the new formed tissue inside the cylinders and after titanium cylinders were removed. Histomorphometry and fluorochrome staining were used to analyse quantity and dynamic of bone formation, respectively. Results showed that DFDBA and fresh-frozen bone improved the velocity and the quantity of bone deposition in distant portions of the basal plane of grafting. Remaining material in allograft groups was more intense than in autogenous group. Both allografts can be indicated as reliable alternatives for volume gain and vertical bone augmentation.

Resumo Várias técnicas foram propostas para regeneração óssea vertical, e muitas delas usam enxertos ósseos e alogênicos ósseos. O objetivo deste estudo foi comparar os aloenxertos ósseos congelados desmineralizados (DFDBA), os aloenxertos congelados frescos (FF) com os enxertos ósseos autógenos para encontrar diferenças entre o volume, a histologia da formação óssea e a dinâmica do crescimento ósseo vertical. Um modelo ósseo de regeneração tecidual vertical foi realizado em calvarias de coelho sob anestesia geral. Quatro cilindros ocos de titânio puro foram parafusados nas calvarias de osso cortical externo em oito coelhos. Cada um dos cilindros foi preenchido aleatoriamente com uma intervenção: DFDBA, FF, osso autógeno ou com coágulo sanguíneo (BC) como controle. Os enxertos alogênicos foram obtidos a partir de um nono animal seguindo protocolos internacionais padronizados para a coleta, processamento e criopreservação de aloenxertos. O enxerto autógeno foi obtido da raspagem do fêmur do hospedeiro antes de adaptar os cilindros ocos. Os animais foram eutanasiados após 13 semanas. O volume vertical foi calculado após a medição, por meio de sonda milimetrada, do novo tecido formado dentro dos cilindros e após a remoção dos cilindros de titânio. Histomorfometria e coloração com fluorocromios foram utilizados para analisar a quantidade e a dinâmica da formação óssea. Os resultados mostraram que DFDBA e osso fresco congelado melhoraram a velocidade e a quantidade de deposição óssea em porções distantes do plano basal de enxerto. O material remanescente nos grupos de aloenxerto foi mais intenso do que em grupo autógeno. Ambos os aloenxertos podem ser indicados como alternativas confiáveis para ganho de volume e aumento ósseo vertical.

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.

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.

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.

OBJECTIVE: 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.

OBJETIVO: 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.

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.

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.