RESUMEN
OBJECTIVE: NovaMin is technically described as amorphous sodium calcium phosphosilicate, and has been shown in laboratory studies to rapidly occlude dentin tubules through the deposition of particles that react to form a protective layer, similar to bone mineral, on the dentin surface. NovaMin was originally developed as a bone regenerative material and is highly biocompatible. The objective of this pilot study was to compare the safety and effectiveness of two prototype formulations containing 2.5% and 7.5% w/w NovaMin to a placebo dentifrice for the treatment of dentin hypersensitivity. METHODS: This was a randomized, double-blind, placebo-controlled pilot study. Sixty-six subjects with a confirmed diagnosis of dentin hypersensitivity were randomized to one of three treatments: 2.5% NovaMin, 7.5% NovaMin, or placebo. Two standard test stimuli, tactile and thermal air, were applied to sensitive cervical dentin surfaces. Subjects recorded the intensity of sensitivity in response to each stimulus on a visual analog scale at baseline, and after two, four, and eight weeks of twice-daily product use. Oral soft tissues were examined and spontaneous reports of adverse experiences were also monitored. RESULTS: Comparison of the mean change from baseline among the three treatment groups indicated a meaningful reduction in sensitivity scores in the 7.5% group that was significant compared to reductions observed in the placebo control group at all time points. CONCLUSION: The results of this study are supportive of the incorporation of NovaMin into products intended for the reduction of dentin hypersensitivity.
Asunto(s)
Dentífricos/uso terapéutico , Desensibilizantes Dentinarios/uso terapéutico , Sensibilidad de la Dentina/tratamiento farmacológico , Vidrio , Adulto , Análisis de Varianza , Dentífricos/administración & dosificación , Desensibilizantes Dentinarios/administración & dosificación , Método Doble Ciego , Femenino , Humanos , Masculino , Dimensión del Dolor , Proyectos Piloto , Seguridad , Silicatos/administración & dosificación , Silicatos/uso terapéutico , Estadísticas no ParamétricasRESUMEN
BACKGROUND: Combination therapy has been widely used for the clinical management of acute pain. By combining 2 drugs with different mechanisms of action, such therapy provides additive analgesic effects while reducing the risk for adverse effects. OBJECTIVE: This study compared the efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg with those of oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, and placebo in a dental pain model. METHODS: This was a multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group, single-dose study in patients experiencing moderate to severe pain after surgical removal of > or = 2 ipsilateral impacted third molars. Patients were randomly assigned to receive oxycodone 5 mg/ibuprofen 400 mg, oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, or placebo. The primary outcome measures were total pain relief through 6 hours after dosing (TOTPAR6), sum of pain intensity differences through 6 hours (SPID6), and adverse events. Secondary efficacy measures included SPID3 and TOTPAR3, peak pain relief, peak pain intensity difference, time to onset of pain relief, time to use of rescue medication, proportion of patients reporting pain half gone, and the patient's global evaluation. RESULTS: Two hundred forty-nine patients (43.5% male; 87.5% white; mean age, 19.1 years; mean body weight, 153.6 pounds) were randomized to treatment as follows: 62 to oxycodone 5 mg/ibuprofen 400 mg, 61 to oxycodone 5 mg/acetaminophen 325 mg, 63 to hydrocodone 7.5 mg/acetaminophen 500 mg, and 63 to placebo. Oxycodone 5 mg/ibuprofen 400 mg provided significantly greater analgesia compared with oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, and placebo (mean [SD] TOTPAR6, 14.98 [5.37], 9.53 [6.77], 8.36 [6.68], and 5.05 [6.49], respectively; P < 0.001, oxycodone 5 mg/ibuprofen 400 mg vs all other treatments). SPID6 values also differed significantly for oxycodone 5 mg/ibuprofen 400 mg compared with all other treatments (mean: 7.78 [4.11], 3.58 [4.64], 3.32 [4.73], and 0.69 [4.85]; P < 0.001). Oxycodone 5 mg/ibuprofen 400 mg was significantly more effective compared with the other treatments on all secondary end points (P < 0.001, all variables except peak PID vs oxycodone 5 mg/acetaminophen 325 mg [P = 0.006]), with the exception of the time to onset of analgesia. The lowest frequency of nausea and vomiting occurred in the groups that received oxycodone 5 mg/ibuprofen 400 mg (6.5% and 3.2%, respectively) and placebo (3.2% and 1.6%). Rates of nausea and vomiting were significantly lower with oxycodone 5 mg/ibuprofen 400 mg compared with oxycodone 5 mg/acetaminophen 325 mg (P = 0.011 and P = 0.009, respectively) but not with hydrocodone 7.5 mg/acetaminophen 500 mg. CONCLUSIONS: In this study in patients with moderate to severe pain after surgery to remove impacted third molars, oxycodone 5 mg/ibuprofen 400 mg provided significantly better analgesia throughout the 6-hour study compared with the other opioid/nonopioid combinations tested, and was associated with fewer adverse events.
Asunto(s)
Acetaminofén/uso terapéutico , Analgésicos no Narcóticos/uso terapéutico , Analgésicos Opioides/uso terapéutico , Antiinflamatorios no Esteroideos/uso terapéutico , Hidrocodona/uso terapéutico , Ibuprofeno/uso terapéutico , Tercer Molar/cirugía , Oxicodona/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Acetaminofén/administración & dosificación , Acetaminofén/efectos adversos , Adulto , Analgésicos no Narcóticos/administración & dosificación , Analgésicos no Narcóticos/efectos adversos , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/efectos adversos , Antiinflamatorios no Esteroideos/administración & dosificación , Antiinflamatorios no Esteroideos/efectos adversos , Método Doble Ciego , Combinación de Medicamentos , Femenino , Humanos , Hidrocodona/administración & dosificación , Hidrocodona/efectos adversos , Ibuprofeno/administración & dosificación , Ibuprofeno/efectos adversos , Masculino , Oxicodona/administración & dosificación , Oxicodona/efectos adversos , Dolor Postoperatorio/clasificaciónRESUMEN
OBJECTIVE: This study compared the efficacy and safety of a single dose of oxycodone 5 mg/ibuprofen 400 mg versus its individual components and placebo in a third-molar extraction model. METHODS: In this multicenter, double-blind, double-dummy, parallel-group investigation, subjects with moderate to severe pain within 5 hours after extraction of > or =2 ipsilateral bony impacted third molars were randomized to single doses of oxycodone 5 mg/ibuprofen 400 mg, ibuprofen 400 mg, oxycodone 5 mg, or placebo. Primary efficacy variables were the sum of pain intensity difference over 6 hours (SP1D6) and total pain relief through 6 hours (TOTPAR6). The pharmacokinetics of oxycodone and ibuprofen, alone and in combination, were also determined in a subset of patients. RESULTS: A total of 498 subjects were randomized to treatment (187 to oxycodone 5 mg/ibuprofen 400 mg, 186 to ibuprofen 400 mg, 63 to oxycodone 5 mg, and 62 to placebo). Baseline demographics were generally similar among treatment groups, despite differences in sex (P = 0.041) and race (P = 0.023). Combination therapy was associated with greater analgesia than ibuprofen alone, oxycodone alone, or placebo (mean [SE] TOTPAR6: 13.3 [0.52], 12.2 [0.52], 4.3 [0.82], and 4.2 [0.83], respectively [P < 0.001 vs oxycodone or placebo, P = 0.012 vs ibuprofen]; mean [SE] SP1D6: 6.54 [0.42], 5.41 [0.44], 0.14 [0.60], and 0.32 [0.59], respectively [P < 0.001 vs oxycodone or placebo, P = 0.002 vs ibuprofen]). Combination therapy was well tolerated. Pharmacokinetic results implied no interaction between oxycodone and ibuprofen. CONCLUSIONS: In this study, a single dose of oxycodone 5 mg/ibuprofen 400 mg was fast-acting, effective, and well tolerated in subjects with moderate to severe pain after dental surgery. Oxycodone 5 mg alone did not provide an efficacy benefit over placebo in this study.
Asunto(s)
Analgésicos Opioides/uso terapéutico , Antiinflamatorios no Esteroideos/uso terapéutico , Ibuprofeno/uso terapéutico , Oxicodona/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Extracción Dental , Adulto , Analgésicos Opioides/farmacocinética , Antiinflamatorios no Esteroideos/farmacocinética , Área Bajo la Curva , Método Doble Ciego , Combinación de Medicamentos , Femenino , Semivida , Humanos , Ibuprofeno/farmacocinética , Masculino , Tercer Molar , Oxicodona/farmacocinética , Dolor Postoperatorio/clasificaciónRESUMEN
New dual-phase fluoride toothpastes that contain soluble calcium, phosphate, and baking soda have recently been introduced into the market. These toothpastes are designed to fill in small surface defects in tooth enamel and thereby enhance tooth esthetics such as gloss. This two-part study was designed to assess these superficial mineralizing effects from using one of these products compared with an experimental calcium-containing, bicarbonate-free formulation and a conventional fluoride toothpaste using an intraoral model. Enamel specimens with 4 types of defects were mounted into an intraoral appliance and placed in the mouths of volunteers for 1 month. The four types of defects were whitening toothpaste abrasion, coarse abrasion, natural dimpling, and acid etching. Before and after intraoral exposure, scanning electron microscope photographs of the specimens were made. The surface microhardness of the acid-etched specimens also was determined. The volunteers brushed their specimens twice daily with one of three randomly assigned toothpastes. The toothpastes were a two-phase, calcium-containing, bicarbonate-based toothpaste; an experimental, two-phase, calcium-containing, bicarbonate-free toothpaste; and a conventional toothpaste. Only the calcium-containing toothpastes showed unequivocal signs of mineral deposition into surface defects, leading to smoothing of the enamel. All three products significantly increased the hardness of the etched enamel, presumably because of fluoride. However, only the two calcium-containing toothpastes gave significantly greater hardness increases than the conventional toothpaste; the specimens treated with a conventional toothpaste were indistinguishable from those treated with saliva.