Metal Release of Standard and Fake Orthodontic  Braces: An In Vitro Study

Nasir, Siti Hajjar; Amran, Muhammad Syahmi Mohamad; Mustaffar, Muhammad Muaz Abidin

doi:10.31436/imjm.v20i2.1707

Cited by 5 publications

(7 citation statements)

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“…In this study, it was noted that releases of Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, and Cd ions were all below 10 mg/L over the 28-day immersion period, with no significant difference to the respective control samples, except for Mo. Nasir et al [ 8 ] also found less than 10 mg/L of Ni, Cr and Mn were released but the differences were significant compared to the control at day 1 for Cr and Mn, and at day 14 for Ni. It can be suggested that a systemic toxic effect from these ions is unlikely for fake braces, but if these results were to be compared with the daily dose recommended by WHO [ 18 ], some of the elements were higher than their limit.…”

Section: Discussionmentioning

confidence: 72%

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Metal ions leachables from fake orthodontic braces incubated in simulated body fluid

2021

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Background The demand for fake braces usage in Southeast Asia are increasing but lack of certification and information on fake braces as medical devices from regulated bodies raised a concern towards its safety. The aim of this study was to determine the types of metal ion leachable from removable fake braces based on heavy metal ions present in metallic materials, immersed in simulated body fluid (SBF) and analysed using inductively coupled plasma atomic emission spectroscopy. Methods Three sets of fake braces and one control were dissembled to only their brackets and archwires and immersed separately in SBF. They were placed in an incubator shaker at a temperature of 37 °C at 50 rpm. A 3.0 ml measurement of SBF was taken out from the sample containers at days 7, 14 and 28 and kept at − 20 °C for further analysis. Data were analysed using SPSS version 26.0 (IBM, Armonk, USA) (P < 0.05). Descriptive and one-way ANOVA analyses with Bonferroni post hoc tests were used to assess the significant differences between the metal ions released in SBF from the control samples and fake braces. Results All 23 elements under investigation except Si ions were detected from the control samples and fake braces. There were significant increased K ions and reduced levels of Mg ions from the fake archwires and brackets. Most ions released were less than 10 mg/L (Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Mo, Cd, Pb, Al) or 1 mg/L (Li, Ba) into the SBF medium. Conclusion There were significant release of Ca and K ions from the fake samples. Elements such as Li, Ba, Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Mo, Cd and Sb had increased in concentration at day 7 and the concentration plateaued until day 28.

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Section: Discussionmentioning

confidence: 72%

“…It was concluded that the bracket surfaces were distinctly inferior to those of the standard brackets and no heavy metals such as Pb, mercury (Hg) and arsenic (As) were present [ 6 ]. Another paper by the same author reported high releases of Cr, Mn and Ni ions from fake orthodontic brackets immersed in artificial saliva [ 8 ].…”

Section: Discussionmentioning

confidence: 99%

Metal ions leachables from fake orthodontic braces incubated in simulated body fluid

2021

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“…A local study identified increased metal ion release from orthodontic brackets bought from online suppliers. 24 The brackets are also presented with rough surfaces, making them prone to corrosion and breakage. 25 Two deaths in Thailand have been linked to the use of 'fake braces', which are commonly sold online.…”

Section: Discussionmentioning

confidence: 99%

Orthodontics on sale: fixed appliances on E-commerce platforms

Kamarudin

Zakaria

Xinhui

2022

Australasian Orthodontic Journal

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Introduction:The sale of orthodontic materials, considered as medical devices, is regulated in order to protect patients. The availability of orthodontic products on e-commerce platforms, however, may go unregulated and compromise patient safety.Objective: The present study aimed to investigate the sale of fixed orthodontic appliances on a local and global e-commerce platform. Materials and Methods: A cross-sectional analysis of orthodontic materials sold on Shopee and Amazon was conducted using a specific keyword search for brackets, arch wires and ligatures. After deleting duplicates and irrelevant search results, the top 50 products for each keyword search were analysed. Product name, the type of product, seller, cost, star rating, the number of reviews, the number of sales, shipping location and brand identification were recorded. Brand registration with a medical device regulatory authority was checked. Collected data were tabulated in Google (spread)sheet to derive descriptive statistics and frequency tables. Results: A total of 800 search results were screened. Three hundred and forty-eight relevant results were identified, approximately two-thirds of which originated from Shopee. Ligatures generated the highest search outcome in both Shopee (39%) and Amazon (80%). Fixed orthodontic materials sold on Shopee resulted in a larger number of reviews, higher star ratings and a lower cost per item compared to those supplied by Amazon. Products on Amazon were more likely to have brand identification (97%) compared to Shopee (5%). None of the identifiable brands on Shopee were registered with regulatory bodies, whereas eight products listed on Amazon were registered. A large portion of shipping locations originated from China for both e-commerce platforms. Conclusions: Orthodontic brackets, arch wires and ligatures are more readily available on Shopee compared to Amazon. The quality and safety of these products cannot be assured as the majority of the products were either not clearly labelled or their registration was not identified under the regulation of medical devices.

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“… Device Material Brand Released ions Study media Exposure time Analysis method Ref. Brackets Wires Fe–Cr–Ni–Mo Co–Cr–Mo–Fe Ti–Al–V Ni–Ti Cu–Ni–Ti Ormodent Cr Ni Fe Artificial saliva Elmex® mouthwash Meridol® mouthwash 2 months ICP-MS SEM Polarization curves [ 3 ] Ortho Plus Ormodent Ormodent Ormodent Brackets Wires SS NiTi SS 3 M Unitek - Tooth paste 12 h Friction test SEM [ 6 ] Brackets SS 3 M Unitek - Artificial saliva pH 4.9 pH 7.8 1 day ICP MS [ 7 ] Forestadent 7 days MEM Dental Technology 28 days Brackets SS Libral Traders - Artificial saliva 24 h Optical microscopy [ 8 ] Sodium chloride Pepper Turmeric Brackets Wires SS SS Ni Ti DynaLock - Artificial saliva Hydrofluoric acid Acid phosphate fluoride 24 h Friction force [ 9 ] Tomy Ormco 3M Unitek Ormco Brackets Wires Coated N...…”

Section: Bracketsmentioning

confidence: 99%