N. Doan, L. Nguyen-Pham, S. Cokim
Energy for Health [15], 2016
This study aim to assess the efficacy of a MLS® Mphi therapeutic laser as an adjunct management of postoperative pain, swelling, and trismus related the surgical extraction of impacted third molars using visual analogue scale (VAS) and satisfaction outcome measure. A cohort of 42 impacted wisdom patients, each underwent surgical extraction of 4 extractions under local anesthetic, were selected for a double-blind, randomized, controlled clinical trial. The two groups of patients were divided into control and study group, each of 21 patients, match my age and sex. Immediately after the extraction procedure, the experimental group received one off 1.27 J/cm2 of energy density intraorally using Mphi laser while the control, group received sham radiation. The degree of postoperative pain, swelling, trismus, and dry socket was registered for both groups at day one, day 7 (one week) and day 28 (4 weeks). Only those normal patients with 4 impacted wisdom teeth required flap approach, and had complete clinical data were included in this study. Using visual analogue scale (VAS = 0 to 10), the study group revealed to have less: pain, swelling, bleeding and speech impairment and had better overall satisfaction at one day and one week than the control counterpart (*P<0.05). No significant difference in pain at 1 months. The study group showed a less dry socket than the control group without statistical significance. All participants in the both groups required analgesics, however, the study group required less pain killer than the control group between day one to day seven. At one week, the study group had less moderate trismus and more mild trismus compare to the control group (P<0.05). The application of ASA Mphi laser in the postoperative management of pain in surgical wisdom teeth extraction statistically produced early stage of satisfaction as well as reduced postoperative pain, swelling, bleeding, speech impairment, analgesics use and trismus.
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Decreto Legislativo 24 febbraio 1997, n°46 Articolo 21
1. E' vietata la pubblicità verso il pubblico dei dispositivi che, secondo disposizioni adottate con decreto del Ministro della Sanità, possono essere venduti soltanto su prescrizione medica o essere impiegati eventualmente con l'assistenza di un medico o di altro professionista sanitario.
2. La pubblicità presso il pubblico dei dispositivi diversi da quelli di cui al comma 1 è soggetta ad autorizzazione del Ministero della Sanità. Sulle domande di autorizzazione esprime parere la Commissione di esperti prevista dall'articolo 6, comma 3, del decreto legislativo
30 dicembre 1992, n. 541, che a tal fine è integrata da un rappresentante del Dipartimento del Ministero della Sanità competente in materia di dispositivi medici e da uno del Ministero dell'Industria, del commercio e dell'artigianato.
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