ABSTRACT
Combined vaccines for childhood are a strategy in the prevention of several diseases. These can maximize protection and decrease immunization schedules in children. New candidates are getting closer to being able to meet these needs, but they raise numerous strategic questions related to formulation and regulatory aspects. In addition to being immunogenic and protective must have low reactogenicity when combined with other antigens. Adjuvants are important components in achieving these combinations. Therefore, a reactogenicity study was designed for two Bordetella pertussis formulations containing hydroxide or aluminum phosphate in Sprague Dawley rats. Both formulations dose were administered in 0.2 mL intramuscularly. Clinical evaluations, body weight, water consumption, food, temperature, muscle volume, dermal irritability and pathological studies with special interest at the inoculation site were carried out. Only differences in body temperature and muscle volume were found with a slight increase in values with return to normal. The macroscopic study showed lesions at the site of inoculation, considered characteristics of aluminum adjuvants, such as granulomatous abscesses and the increase in regional lymph nodes near the inoculation site. As conclusion, there are no differences between the formulations of B. pertussis with hydroxide or aluminum phosphate resulted in low reactogenicity.
Las vacunas combinadas resultan una estrategia importante en la obtención de vacunas múltiples para la infancia y el uso de adyuvantes es un componente de gran valor en lograr estas combinaciones, además de ser inmunogénicas y protectoras deben tener baja reactogenicidad, cuando se combinan con diferentes antígenos. Por esta razón, se diseñó un estudio de reactogenicidad a dos formulaciones que contenían hidróxido y fosfato de aluminio con antígenos de Bordetella pertussis en ratas Sprague Dawley. Se administró a cada grupo de ensayo una dosis correspondiente de ambas formulaciones en 0,2 mL por vía intramuscular. Se realizaron observaciones clínicas, comportamiento del peso corporal, consumo de agua, alimentos, temperatura corporal, volumen muscular, irritabilidad dérmica y estudios anatomopatológicos macroscópicos, con especial interés en el sitio de inoculación. No se observaron síntomas, ni muertes en los animales durante el estudio. Tampoco se encontraron diferencias entre los grupos experimentales en cuanto al peso corporal, el consumo de agua y de alimentos; los estudios de temperatura corporal y volumetría muscular evidenciaron un ligero incremento en los valores, los cuales involucionaron rápidamente a la normalidad. En el estudio anatomopatológico macroscópico se observaron lesiones a nivel del punto de inoculación, consideradas propias de los adyuvantes que contienen aluminio, tales como formaciones abscedadas de tipo granulomatosas y el aumento de los ganglios linfáticos regionales cercanos al punto de inoculación. Se concluye que las formulaciones en hidróxido y fosfato de aluminio con antígenos de B.pertussis resultaron ser de baja reactogenicidad.
Subject(s)
Animals , Rats , Adjuvants, Pharmaceutic/adverse effects , Aluminum Compounds/adverse effects , Injection Site Reaction , Pertussis Vaccine , Rats, Sprague-DawleyABSTRACT
Abstract This systematic review aimed to evaluate whether alternative materials to conventional triple antibiotic paste (TAP - metronidazole, ciprofloxacin, and minocycline) and grey mineral trioxide aggregate (GMTA) could avoid tooth discoloration in teeth submitted to Regenerative Endodontic Procedure (REP). It was also investigated if dental bleaching is able to reverse the color of darkened teeth due to REP. The search was conducted in four databases (Medline via PubMed, Scopus, ISI Web of Science and BVS - Virtual health library), following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The retrieved papers were uploaded in the software EndNoteTM and two reviewers independently selected the studies and extracted the data. Only studies in humans (case reports, case series, clinical trials) were included in the review. From 1,122 potentially eligible studies, 83 were selected for full-text analysis, and 38 were included in the review. The included studies were mainly case reports (76.3 %). The studies described a total of 189 teeth submitted to REP. From these, about 54% of teeth presented some degree of discoloration. Most teeth presenting color alteration were treated with TAP, especially when combined with GMTA. Only three studies performed dental bleaching to restore the color of teeth and neither bleaching technique was able to restore the original color of the crowns. The use of alternative materials to TAP and GMTA, such as double antibiotic paste or Ca(OH)2 pastes and white mineral trioxide aggregate or BiodentineTM, reduces the occurrence of tooth discoloration.
Resumo Esta revisão sistemática teve como objetivo avaliar se materiais alternativos à pasta tri-antibiótica convencional (TAP, em Inglês - metronidazol, ciprofloxacina e minociclina) e ao agregado trióxido mineral cinza (MTA cinza) poderiam evitar a descoloração dentária em dentes submetidos ao procedimento endodôntico regenerativo (REP, em Inglês). Também foi investigado se o clareamento dental é capaz de reverter a cor dos dentes escurecidos devido ao REP. A busca foi realizada em quatro bases de dados (Medline via PubMed, Scopus, ISI Web of Science e BVS - Biblioteca Virtual de Saúde), seguindo os Principais Itens para Relatar Revisões Sistemáticas e Meta-análises. Os artigos obtidos foram carregados no software EndNoteTMe dois revisores independentes selecionaram os estudos e extraíram os dados. Apenas estudos em humanos (relatos de casos, séries de casos, ensaios clínicos) foram incluídos na revisão. De 1.122 estudos potencialmente elegíveis, 83 foram selecionados para análise do artigo completo, e 38 foram incluídos na revisão. Os estudos incluídos foram principalmente relatos de casos (76,3%). Os estudos descreveram um total de 189 dentes submetidos ao REP. Destes, cerca de 54% dos dentes apresentaram algum grau de descoloração. A maioria dos dentes com alteração de cor foi tratada com TAP, principalmente quando combinada com MTA-cinza. Apenas três estudos realizaram o clareamento dental para restaurar a cor dos dentes e nem a técnica de clareamento conseguiu restaurar a cor original das coroas. O uso de materiais alternativos à TAP e ao MTA cinza, como a pasta bi-antibiótica, pasta de Ca(OH)2e MTA branco ou BiodentineTM, reduz a ocorrência de descoloração dentária.
Subject(s)
Humans , Tooth Discoloration/chemically induced , Tooth Discoloration/prevention & control , Regenerative Endodontics , Oxides/adverse effects , Root Canal Filling Materials/adverse effects , Tooth Bleaching , Silicates/adverse effects , Calcium Compounds/adverse effects , Aluminum Compounds/adverse effects , Drug Combinations , Anti-Bacterial Agents/adverse effectsABSTRACT
Crown discoloration can be induced by root canal sealer remnants following root canal treatment. Objective: The aim of this study was to evaluate chromatic alterations in human tooth crowns induced by a Mineral Trioxide Aggregate-based sealer (MTA Fillapex®) and a commonly used ZnOE-based sealer (Roth-811). The tested null hypothesis was that the application of the materials did not induce clinically perceptible crown discoloration (Ho: CIE color difference ΔE<3.7). Material and Methods: Forty five fully developed, intact, mandibular third molars were sectioned 1 mm below the cemento-enamel junction. The pulp chambers were chemomechanically debrided via the cervical access. The specimens were randomly assigned into three groups Group 1: MTA Fillapex, Group 2: Roth 811, Group 3: Negative control (unfilled) and immersed in individually marked vials containing distilled water up to the cervix (37±1°C). The spectral reflectance lines were recorded by utilizing a UV-VIS spectrophotometer equipped with integration sphere in the visual spectrum at baseline, 1 week, 1 and 3 months after material placement. Data were transformed into values of the CIE L*a*b* color system and the corresponding ΔE values were calculated. Statistical analysis was performed using two-way mixed ANOVA models, at p=0.05 level of significance. Results: A statistically significant increase in a* and b* chromatic parameters of the MTA Fillapex Group was measured. However, ΔE values did not exceed the human eye perceptibility threshold (set at ΔE<3.7) during the experimental period (ΔEt3=2.88). In Roth-811 Group, a statistically significant decrease in L* and a statistically significant increase in a* and b* chromatic parameters was measured, during all observation periods. Resultant ΔE values exceeded the human eye perceptibility threshold after 1 week (ΔEt1=5.65). Conclusions: Application of MTA Fillapex in tooth crowns resulted in minimal color alterations, while Roth 811 induced severe discoloration, in vitro. It could be suggested that, in terms of aesthetics, the use of MTA Fillapex appears to be favorable.