Fittler Márton, Rozmer Zsuzsanna, Fittler András
Department of Dentistry, Oral and Maxillofacial Surgery, Medical School, University of Pécs, Pécs, Hungary.
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Pécs, Pécs, Hungary.
Heliyon. 2023 Aug 28;9(9):e19463. doi: 10.1016/j.heliyon.2023.e19463. eCollection 2023 Sep.
/Purpose: Online vendors seize the advantage of the high demand on home-use, do-it-yourself dental bleaching products. The study aims to present the uncontrolled online market of dental products and provide evidence of consumer safety risks associated with the utilization of high peroxide content bleaching products without dentist's supervision, and also to identify misleading and insufficient information on content and compromised product quality.
A complex risk-based methodology was used including website content evaluation focusing on ingredients, precautionary statements and directions for use provided by online retailers. Bleaching products were test procured in which packaging and labels were documented and assessed. Quality control was performed using the permanganometric method per the official European Pharmacopoeia.
One (16.7%) of six test procured peroxide gels was not delivered. Another arrived without enclosed description or instructions. The ingredient list was incomplete or missing for all (100%) online products, however, it was listed on the label or in enclosed documentation in four out of five (80%) samples. Precautionary statements were scarcely (16.7%) disclosed online, contrarily, safety claims were emphasized by most (83.3%) websites. Contraindications and adverse effects were mentioned in the majority (80%) of the delivered product labels. One sample contained no active principle, in two sample' peroxide content exceeded the label's claim by 5.2-9.0% while in another two it was below the concentration indicated on the labels by 79.9-80.7%.
Dissimilarity in regulations elicits an opportunity for consumers to purchase inappropriately labeled, questionable quality, high peroxide content dental products without information regarding ingredients, application and risks. The uncontrolled market, easy access and unsupervised application of high peroxide-content teeth whiteners imply patient safety issues.
/目的:在线销售商利用家用、自行操作的牙齿美白产品的高需求优势。本研究旨在呈现不受监管的牙齿美白产品在线市场,提供与在无牙医监督情况下使用高过氧化物含量美白产品相关的消费者安全风险证据,并识别有关产品成分、质量受损以及误导性和不充分信息。
采用了一种基于复杂风险的方法,包括对网站内容进行评估,重点关注在线零售商提供的成分、预防声明和使用说明。对美白产品进行测试采购,并记录和评估其包装及标签。按照欧洲药典的高锰酸盐法进行质量控制。
六次测试采购的过氧化物凝胶中有一次(16.7%)未送达。另一次送达时没有附带产品说明或使用指南。所有(100%)在线产品的成分列表均不完整或缺失,但在五分之四(80%)的样品中,成分列于标签或随附文件中。预防声明在网上很少披露(16.7%),相反,大多数网站(83.3%)强调了安全性声明。大多数(80%)已交付产品标签中提到了禁忌和不良反应。一个样品不含活性成分,两个样品的过氧化物含量超出标签声称量5.2 - 9.0%,而另外两个样品的过氧化物含量低于标签所示浓度79.9 - 80.7%。
法规差异为消费者提供了机会,使其能够购买标签不当、质量存疑、过氧化物含量高且缺乏成分、使用方法及风险信息的牙齿美白产品。高过氧化物含量牙齿美白剂的市场不受监管、易于获取且使用无监督,这意味着存在患者安全问题。