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Detecting Bisphenol A Leaching from Four Different Commercially Available Clear Aligner Sheets: An Ex Vivo Study
Nivedha Azhagudurai1, Ramya Rajendran2, K Aishwarya3
1Department of Orthodontics and Dentofacial Orthopaedics, Adhiparasakthi Dental College and Hospital, Melmaruvathur, Tamil Nadu, India, Phone: +91 8939564134; 8939124134,
The Journal of Contemporary Dental Practice
|October 4, 2024
Summary
Bisphenol A (BPA) leaching from clear aligners is highest in the first 24 hours. Duran aligners showed the most BPA leaching, raising biocompatibility concerns for clear aligner therapy (CAT).
Area of Science:
- Biomaterials Science
- Dental Materials
- Analytical Chemistry
Background:
- Clear aligner therapy (CAT) is increasingly popular for orthodontic treatment.
- Concerns exist regarding the biocompatibility of materials used in clear aligners, specifically potential chemical leaching.
- Bisphenol A (BPA) is a chemical compound found in some plastics that warrants investigation for leaching from dental devices.
Purpose of the Study:
- To detect and quantify Bisphenol A (BPA) leaching into saliva from four distinct, commercially available clear aligner materials.
- To assess the kinetics of BPA leaching over a 7-day period during clear aligner wear.
- To compare the BPA leaching profiles among the evaluated clear aligner brands.
Main Methods:
- Twenty volunteers were enrolled and divided into four groups, each receiving one of four different clear aligner brands (Monoflex®, Erkodur®, Leone®, Duran®).
- Salivary samples were collected at baseline (day 0) and at days 1, 5, and 7 post-insertion.
- Liquid chromatography/mass spectrometry (LC/MS) was employed to measure BPA concentrations in salivary samples, comparing baseline to subsequent time points.
Main Results:
- A mean BPA leaching of 0.74 ± 0.33 ppm was observed at day 1 (T1) across all aligner groups.
- No detectable BPA leaching was found at days 5 (T5) and 7 (T7).
- Duran® aligners exhibited the highest BPA leaching at T1 (1.24 ppm), followed by Monoflex® (0.76 ppm), Erkodur® (0.56 ppm), and Leone® (0.43 ppm).
Conclusions:
- BPA leaching from clear aligners is predominantly significant within the initial 24 hours of use.
- Among the tested materials, Duran® demonstrated the least favorable safety profile regarding BPA leaching, with Monoflex®, Erkodur®, and Leone® showing progressively lower levels.
- While leaching levels were minimal, the cumulative effect of BPA exposure during prolonged clear aligner therapy warrants consideration for patient biocompatibility.
