Assessment of Efficacy and Safety of Arterolane Maleate-Piperaquine Phosphate Dispersible Tablets in Comparison With Artemether-Lumefantrine Dispersible Tablets in Pediatric Patients With Acute Uncomplicated Plasmodium falciparum Malaria: A Phase 3, Randomized, Multicenter Trial in India and Africa.

BACKGROUND: Administration of artemisinin-based combination therapy (ACT) to infant and young children can be challenging. A formulation with accurate dose and ease of administration will improve adherence and compliance in children. The fixed-dose combination dispersible tablet of arterolane maleate (AM) 37.5 mg and piperaquine phosphate (PQP) 187.5 mg can make dosing convenient in children. METHODS: This multicenter (India and Africa), comparative, parallel-group trial enrolled 859 patients aged 6 months to 12 years with Plasmodium falciparum malaria. Patients were randomized in a ratio of 2:1 to AM-PQP (571 patients) once daily and artemether-lumefantrine (AL) (288 patients) twice daily for 3 days and followed for 42 days. RESULTS: The cure rate (ie, polymerase chain reaction-corrected adequate clinical and parasitological response) in the per-protocol population at day 28 was 100.0% and 98.5% (difference, 1.48% [95% confidence interval {CI}, .04%-2.91%]) in the AM-PQP and AL arms, respectively, and 96.0% and 95.8% (difference, 0.14% [95% CI, -2.68% to 2.95%]) in the intention-to-treat (ITT) population. The cure rate was comparable at day 42 in the ITT population (AM-PQP, 94.4% vs AL, 93.1%). The median parasite clearance time was 24 hours in both the arms. The median fever clearance time was 6 hours in AM-PQP and 12 hours in the AL arm. Both the treatments were found to be safe and well tolerated. Overall, safety profile of both the treatments was similar. CONCLUSIONS: The efficacy and safety of fixed-dose combination of AM and PQP was comparable to AL for the treatment of uncomplicated P. falciparum malaria in pediatric patients. CLINICAL TRIALS REGISTRATION: CTRI/2014/07/004764.

Assessment of efficacy and post-bleaching sensitivity of home bleaching using 10% carbamide peroxide in extended and non-extended bleaching trays.

AIM: This study aimed to compare the effect of extended margin and conventional bleaching trays on tooth bleaching and tooth sensitivity. METHOD AND METHODS: Twenty subjects (18-56 years) were investigated in a split arch design clinical study that was conducted in a general dental practice. Each subject received a custom made bleaching tray and 10% carbamide peroxide gel. The bleaching trays had the borders extended 5 mm beyond the gingival margins on the right side and finished just at the gingival margin on the left side. Shade change and tooth sensitivity were the primary outcomes studied and analysed in this study. The shade of the six upper and lower anterior teeth was assessed using a value-ordered shade guide before, one week and two weeks after treatment. Sensitivity was self-assessed using a visual analogue scale (VAS) at the end of the first and second weeks of the study. RESULTS: At the end of week two, the mean shade change was 5.01 (± 3.37) and 5.10 (± 3.36) for teeth covered by extended and non-extended tray design, respectively. The mean VAS sensitivity scores for teeth covered by extended and non-extended tray design were 0.96 (± 1.39) and 0.66 (± 0.96), respectively. There was no significant statistical difference between the two designs at any assessment point with regard to shade change and sensitivity (p >0.05). CONCLUSIONS: It can be concluded that an extended tray design confers no superior effect in terms of the whitening outcome achieved or in reducing levels of sensitivity. Thus, both tray designs can be used depending on a dentist's personal preference.

Assessment of the release of mercury from silver amalgam alloys exposed to different 10% carbamide peroxide bleaching agents.

This in vitro study assessed the amount of mercury (Hg) released from a silver amalgam alloy following the application of different 10% carbamide peroxide bleaching agents. A total of 30 specimens (2 mm thick x 4 mm in diameter) were stored in deionized water at 37°C for 7 days. Next, the control group (n = 10) remained in the deionized water for 15 days, while the remaining samples were exposed to 1 of 2 bleaching agents (n = 10) for 8 hours daily (total exposure = 120 hours); for the remaining 16 hours, specimens in the test groups were stored in deionized water at 37°C under relative humidity. After this period, the quantity of Hg in the deionized water was assessed (using atomic absorption spectrophotometry) and compared to the amount of Hg at baseline. The results indicate that exposing amalgam alloys to bleaching agents released greater amounts of Hg compared to exposing samples to deionized [corrected] water.

Effect of dietary supplementation with olive pomaces on the performance and meat quality of growing rabbits.

The aim was to investigate the effects of three types (A, B and C) of stoned and dehydrated olive pomaces (OPs), differing in olive cultivar, on productive performance and meat quality of growing rabbits. The inclusion of OPs (5%) negatively affected the performance of rabbits as it reduced the feed intake, growth rate, carcass weight and dressing out percentage (P<0.05). Compared with the control, the meat of OP rabbits had a greater amount of monounsaturated and a lower amount of polyunsaturated fatty acids (P<0.05), independent of the type of OP used. Oxidative processes in the meat of OPA and OPB were higher (P<0.05), whereas OPC showed the same levels as the control group. This was due to the higher total polyphenol concentration and to the concomitant lower peroxide value of OPC. These results recommend the use of OP in rabbit diet with caution, taking into account the quality of the by-product in terms of oxidative status.

Over-the-counter whitening agents: a concise review.

Tooth discoloration is commonly found in the dental clinic and tooth bleaching has been considered the preferred esthetic alternative, being more conservative, safe and with predictable results. Supervised home-use of 10% Carbamide Peroxide (CP) bleaching with custom-trays is the most common bleaching procedure dispensed by dentists to their patients. The good results obtained with this technique stimulated the flourishing of new products and techniques. Over-the-counter (OTC) bleaching products appeared as a low-cost alternative to bleach discolored teeth without dentist supervision. Different OTC products are available in supermarkets, drug stores or on the Internet, including rinses, paint-on brushes, toothpastes, chewing guns, dental floss, and whitening strips. There is lack of clinical evidence regarding the safety and effectiveness of these products, being most of the studies supported by the manufacturers'. Basically, toothpastes, chewing gums, and dental floss are removal agents of superficial stains. Rinses and paint-on brushes with low levels of hydrogen peroxide have some whitening effect, but without clinical relevance. Strips present similar esthetic results and side-effects, compared to bleaching with 10% CP using trays; however, the studies have financial support from the manufacturers and were based on short term evaluations. Legislation varies widely in different countries regarding OTC dental bleaching. Concerns have appeared due to the potential abusive use of these self-medication agents, especially in young patients, with potential harmful results. Dentists should be acquainted with this kind of products to be able to inform their patients. In conclusion, there is a need for independent clinical trials to provide sufficient evidence regarding the use of OTC bleaching products.

Over-the-counter whitening agents: a concise review

Tooth discoloration is commonly found in the dental clinic and tooth bleaching has been considered the preferred esthetic alternative, being more conservative, safe and with predictable results. Supervised home-use of 10 percent Carbamide Peroxide (CP) bleaching with custom-trays is the most common bleaching procedure dispensed by dentists to their patients. The good results obtained with this technique stimulated the flourishing of new products and techniques. Over-the-counter (OTC) bleaching products appeared as a low-cost alternative to bleach discolored teeth without dentist supervision. Different OTC products are available in supermarkets, drug stores or on the Internet, including rinses, paint-on brushes, toothpastes, chewing guns, dental floss, and whitening strips. There is lack of clinical evidence regarding the safety and effectiveness of these products, being most of the studies supported by the manufacturers'. Basically, toothpastes, chewing gums, and dental floss are removal agents of superficial stains. Rinses and paint-on brushes with low levels of hydrogen peroxide have some whitening effect, but without clinical relevance. Strips present similar esthetic results and side-effects, compared to bleaching with 10 percent CP using trays; however, the studies have financial support from the manufacturers and were based on short term evaluations. Legislation varies widely in different countries regarding OTC dental bleaching. Concerns have appeared due to the potential abusive use of these self-medication agents, especially in young patients, with potential harmful results. Dentists should be acquainted with this kind of products to be able to inform their patients. In conclusion, there is a need for independent clinical trials to provide sufficient evidence regarding the use of OTC bleaching products.

The safety-in-use of 10% carbamide peroxide (Opalescence) for bleaching teeth under the supervision of a dentist.

Fears that the dentist-supervised use of a product that contains carbamide peroxide and that emits hydrogen peroxide may not be safe from the viewpoints of toxicity and cancer risk were engendered by unrealistic animal tests. These fears prompted the UK Government Departments of Trade and Industry (DTI) and of Health (DOH) to try to prohibit the marketing of Opalescence (manufactured by Ultradent Inc.). Faced with the fact that Opalescence had already been awarded a CE mark under the EC Medical Devices Directive, the DTI and DOH attempted to bring about its prohibition by reclassifying Opalescence as falling under the EC Cosmetics Directive, according to which the marketing of products containing more than 0.1% hydrogen peroxide is not permitted.