Abstract
Abstract Background With minimal manufacturer information, a variety of ‘generic’ orthodontic brackets are available online from overseas distributors. The present study investigated the metal composition of generic orthodontic brackets compared with two well-known ‘proprietary’ brands. Materials and methods Ranging in price from AU$2.99 to $65, five sets of different generic brackets were obtained directly from China via eBay (G1, G2…G5). Proprietary brackets were obtained from American Orthodontics (P1) and Rocky Mountain Orthodontics (P2). The 11, 12, 13 and 14 brackets from each set were liquefied in an acid solution and subjected to trace element analysis using inductively coupled plasma mass spectrometry (ICP-MS) and inductively coupled plasma optical emission spectroscopy (ICP-OES) with respect to nickel, chromium, iron, copper, molybdenum, manganese, cadmium, mercury, arsenic and lead. Statistical analysis investigated the compositional consistency within and between each brand. Results The composition of P1 and P2 agreed with the manufacturer’s data. The generic groups typically had low molybdenum and higher copper content and approximated either 17-4 or AISI304 stainless steels or a combination of both. No relationship between brand and consistency of manufacture could be identified. The cheapest bracket contained lead. Conclusions Generic and proprietary brackets showed differences in their metal composition that may have biocompatibility implications.
Highlights
In many jurisdictions, orthodontic appliances are classified as ‘biomedical devices’ and their importation and use fall under the control of regulatory bodies such as the Food and Drug Administration (FDA) in the United States and the Therapeutic Goods Administration (TGA) in Australia
The results produced by the inductively coupled plasma mass spectrometry (ICP-MS) and inductively coupled plasma optical emission spectroscopy (ICP-OES) analyses were in agreement for all elements except for Cr
The Cr results were too high for accurate determination with ICP-MS as they were outside the calibration range for the method
Summary
Orthodontic appliances are classified as ‘biomedical devices’ and their importation and use fall under the control of regulatory bodies such as the Food and Drug Administration (FDA) in the United States and the Therapeutic Goods Administration (TGA) in Australia. Dentists have drawn media attention by Dental products widely available online include orthodontic brackets. Many of these ‘generic’ orthodontic attachments are a fraction of the cost of locally supplied brackets and typically lack detailed information about their origin or manufacture. A variety of ‘generic’ orthodontic brackets are available online from overseas distributors. The present study investigated the metal composition of generic orthodontic brackets compared with two well-known ‘proprietary’ brands. Materials and methods: Ranging in price from AU$2.99 to $65, five sets of different generic brackets were obtained directly from China via eBay (G1, G2...G5). Conclusions: Generic and proprietary brackets showed differences in their metal composition that may have biocompatibility implications. Conclusions: Generic and proprietary brackets showed differences in their metal composition that may have biocompatibility implications. (Aust Orthod J 2018; 34: 163-170)
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