ABSTRACT
OBJECTIVES: To assess the safety and efficacy of an oleanolic acid (OA)-containing toothpaste in reducing gingival inflammation and plaque in patients with gingivitis. METHODS: This proof-of-concept parallel, double-blind, randomized controlled clinical trial included 99 patients. Following a 1-week washout, patients were randomized into three groups: OA group (fluoride toothpaste containing 0.1% OA and placebo mouthwash); negative control (fluoride toothpaste and placebo mouthwash); and CHX group (fluoride toothpaste and 0.12% chlorhexidine mouthwash). Patients were clinically assessed at inclusion, pre-washout visit, baseline and after 4 days, 1 week and 2 weeks of twice-daily use of the products. Patients received a diary for documentation of bleeding on brushing and provided unstimulated saliva samples. RESULTS: After two weeks, all groups showed significant reductions in all clinical parameters. The CHX group exhibited significantly greater reductions in gingival index and interproximal gingival index scores at week 2, as compared to patients in the negative control (p = 0.04). In contrast, reductions in gingival index scores did not differ between CHX and OA groups and between OA and negative control groups at week 2. The CHX group had significantly greater reductions in plaque index scores at day-4, 1-week and 2-week evaluations, as compared to the negative control and OA groups. The frequency of adverse events was similar among the groups. None of the groups reduced salivary transferrin levels. Finally, the OA group had the lowest percentage of self-reported bleeding events. CONCLUSION: OA toothpaste failed to provide antiplaque and antigingivitis effects superior to those of a fluoride toothpaste after 2 weeks of use.
Subject(s)
Dental Plaque , Gingivitis , Oleanolic Acid , Dental Plaque/prevention & control , Dental Plaque Index , Double-Blind Method , Gingivitis/prevention & control , Humans , Oleanolic Acid/therapeutic use , Toothpastes/therapeutic useABSTRACT
Objetivo: describir la incidencia y el pronóstico de la vasculopatía del injerto cardíaco (CAV: cardiac allograft vasculopathy, su sigla en Inglés), de acuerdo con la clasificación propuesta por la Sociedad Internacional de Trasplante de Corazón y Pulmón (ISHLT). Metodología: estudio de cohortes de trasplantados cardíacos, llevado a cabo entre febrero de 2003 y noviembre de 2011 con seguimiento angiográfico; el desenlace principal fue CAV de acuerdo con la ISHLT. Se utilizaron pruebas de chi-cuadrado para variables cualitativas y t de student para las cuantitativas. Se hizo análisis de supervivencia de Kaplan-Meier. Resultados: se incluyeron 118 pacientes; 83,1% fueron hombres con mediana de edad de 46,4 RIQ (38,4-55,6) años. El seguimiento promedio fue de 5 + 4,7 años con 2,4 + 1,6 coronariografías/paciente. La incidencia total de CAV fue de 23,7%; grado 1 (leve) 11,9%, grado 2 (moderada) 7,6% y grado 3 (severa) 4,2%. El único factor con una asociación modesta fue la hipertensión pulmonar con RR 2,54 (1,1-6,1) p=0,05. La mortalidad de los pacientes de acuerdo con el grado de vasculopatía fue: leve 0%; grado 2 (moderada) 42% RR 2,59 IC95% (1,14-5,9) p=0,024; grado 3 (severa) 72% RR 4,44 IC95% (2,27-8,6) p<0,0005. Conclusiones: la incidencia de CAV fue de 23,7%. El único factor modestamente relacionado fue la hipertensión pulmonar. La escala propuesta por la ISHLT se asocia en sus grados 2 y 3 (moderada y severa) con mortalidad importante.
Objective: to describe the incidence and prognosis of cardiac allograft vasculopathy (CAV: cardiac allograft vasculopathy) according to the classification proposed by the International Society for Heart and Lung Transplantation (ISHLT). Methodology: cohort study of heart transplant recipients conducted between February 2003 and November 2011 with angiographic follow-up. The primary outcome was CAV according to the ISHLT. We used chi-square tests for categorical variables and Student t test for quantitative variables. Kaplan-Meier survival analysis was made. Results: 118 patients were included. 83.1% were male with a mean age of 46.4 IQR (38.4 to 55.6) years. The average follow-up was 5 + 4.7 years with 2.4 + 1.6 coronary angiograms / patient. The overall incidence of CAV was 23.7%. Grade 1 (mild) 11.9%, grade 2 (moderate) 7.6% and grade 3 (severe) 4.2%. The only factor with a modest association was pulmonary hypertension with RR 2.54 (1.1 to 6.1) p = 0.05. The mortality of patients according to the degree of vasculopathy was: mild 0%, grade 2 (moderate) 42% RR 2.59 CI 95% (1.14 to 5.9) p = 0.024; Grade 3 (severe) 72 % RR 4.44 95% CI (2.27 to 8.6) p <0.0005. Conclusions: the incidence of CAV was 23.7%. The only factor modestly related was pulmonary hypertension. The scale proposed by the ISHLT is associated in grades 2 and 3 (moderate and severe) with significant mortality.
