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Hyaluronic Acid-Based Medical Device for Treatment of Alveolar Osteitis—Clinical Study

机译:基于透明质酸的医疗设备治疗肺泡性骨炎的临床研究

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摘要

Alveolar Osteitis (AO) is a complication following the extraction of a tooth. AO manifests through localized pain in, and around, the extraction site, where the post-operative blood clot has been disintegrated. The aim of this single cohort study was to evaluate the outcome of a treatment of AO, using a pharmacological device composed of hyaluronic acid and octenidine dihydrochloride. The tested device is a sponge-like material, composed solely of a fully dissoluble medicaments (hyaluronic acid, calcium chloride, and octenidine dihydrochloride). It was designed to serve as a non-toxic, slow-dissolving antiseptic, that adheres to mucosa and obturates the wound. This study includes 58 subjects who were diagnosed with AO. The tested device was administered once daily until local pain subsided to < 20 mm of the Visual Analog Scale (VAS). The treatment was considered effective when the pain subsided to < 20 mm VAS in < 8 days of treatment; as per comparative studies. Our findings provide a statistically significant success rate of 96.0% (95.0% confidence interval of 75.75% to 97.8%) after pharmacological device administrations. No adverse medical effects were detected. Acquired data confirmed that lyophilized hyaluronic acid, combined with octenidine, is effective for the treatment of AO. The results are clinically important as AO is a common complication after third molar extractions.
机译:牙槽骨炎(AO)是拔牙后的并发症。 AO通过提取部位及其周围的局部疼痛表现出来,在该部位,术后血块已经分解。这项单一队列研究的目的是使用由透明质酸和盐酸奥替尼定组成的药理装置评估AO治疗的结果。被测试的设备是海绵状材料,仅由完全溶解的药物(透明质酸,氯化钙和辛烯二盐酸盐)组成。它被设计用作无毒,溶解缓慢的防腐剂,可粘附在粘膜上并阻塞伤口。该研究包括58位被诊断患有AO的受试者。每天一次使用被测设备,直到局部疼痛减轻至视觉模拟量表(VAS)的<20 mm。当在<8天的治疗中疼痛减轻至<20 mm VAS时,认为该治疗有效;根据比较研究。我们的发现在药理装置给药后提供96.0%(95.0%置信区间为75.75%至97.8%)的统计学显着成功率。没有发现不利的医学影响。获得的数据证实,冻干的透明质酸与辛烯啶合用可有效治疗AO。该结果在临床上很重要,因为AO是第三磨牙拔除后的常见并发症。

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