Introduction:Tuberous sclerosis complex is a rare genetic disorder leading to the growth of hamartomas in multiple organs, including cardiac rhabdomyomas. Children with symptomatic cardiac rhabdomyoma require frequent admissions to intensive care units, have major complications, namely, arrhythmias, cardiac outflow tract obstruction and heart failure, affecting the quality of life and taking on high healthcare cost. Currently, there is no standard pharmacological treatment for this condition, and the management includes a conservative approach and supportive care. Everolimus has shown positive effects on subependymal giant cell astrocytomas, renal angiomyolipoma and refractory seizures associated with tuberous sclerosis complex. However, evidence supporting efficacy in symptomatic cardiac rhabdomyoma is limited to case reports. The ORACLE trial is the first randomised clinical trial assessing the efficacy of everolimus as a specific therapy for symptomatic cardiac rhabdomyoma.Methods:ORACLE is a phase II, prospective, randomised, placebo-controlled, double-blind, multicentre protocol trial. A total of 40 children with symptomatic cardiac rhabdomyoma secondary to tuberous sclerosis complex will be randomised to receive oral everolimus or placebo for 3 months. The primary outcome is 50% or more reduction in the tumour size related to baseline. As secondary outcomes we include the presence of arrhythmias, pericardial effusion, intracardiac obstruction, adverse events, progression of tumour reduction and effect on heart failure.Conclusions:ORACLE protocol addresses a relevant unmet need in children with tuberous sclerosis complex and cardiac rhabdomyoma. The results of the trial will potentially support the first evidence-based therapy for this condition.

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Background: Epidemiological Surveillance Systems are part of public policies to evaluate the impact of prevention interventions or the occurrence of related health events. In Dental Public Health has been valuable the surveillance systems to follow the fluoridation programs, the prevalence of caries or the fluorosis cases. Purpose: Identify and summarize published information regard the status of fluoridation programs and their epidemiological surveillance systems in Latin America and the Caribbean region. Methods: In this narrative literature review, articles searches in Medline and LILACS, in four languages, was carried out. Results: The authors included the analysis of 291 references published by government entities, international agencies, academic institutions and other sources, and summarizing the synthesis of all findings in two tracking matrices to contribute with new knowledge for policy making and program improvement through monitory systems. The results showed 11 active programs, 18 in uncertain status, and one country projecting a future program. Only six countries that started their fluoridation programs in the mid-eighties in the twentieth century have structured or strengthened a surveillance system for their fluoridation programs. Conclusions: The authors recommend a new stage of international accompaniment by several agencies to resume fluoridation programs in countries where structural, economic, or political factors affected the implementation or continuation of fluoridation programs in the 21st century.