A systematic review of biocompatibility and safety of orthodontic clear aligners and transparent vacuum-formed thermoplastic retainers: Bisphenol-A release, adverse effects, cytotoxicity, and estrogenic effects.

Background: An ever-increasing demand is seen for clear aligners and transparent vacuum-formed retainers. They are esthetic and convenient. However, the biomaterials used in these appliances might pose biological safety and biocompatibility threats in terms of their bisphenol-A (BPA) release, cytotoxicity, adverse effects, and estrogenic effects. Due to the controversial results and the lack of any systematic reviews in this regard, we conducted this systematic review. Materials and Methods: Web of Science, PubMed, Cochrane, Scopus, and Google Scholar as well as references of the found articles were searched (independently by 3 researchers) up to December 22, 2021, to find studies relevant to the biocompatibility of clear aligners and thermoplastic retainers. The search keywords were a combination of the following (and more): Essix, vacuum-formed aligner, thermoplastic aligner, clear aligner, Invisalign, vacuum-formed retainer, BPA release, monomer release, cytotoxicity, estrogenicity, biocompatibility, chemical properties, and oral epithelial cell. As eligibility criteria, articles in all languages would be included as long as their text could be translated clearly using online translators or by professional translators; all types of publications (article, book, and thesis) would be included if containing relevant studies and information; they should have been on clear liners or thermoplastic retainers; and they should have been on biocompatibility, safety, cytotoxicity, or estrogenicity of clear aligners or thermoplastic retainers. There were no restrictions on the type of study (randomized clinical trials, experimental in vitro studies). Studies focusing merely on the mechanical properties of clear aligners or thermoplastic retainers (without examining their chemical properties) would be excluded. The risk of bias was assessed. Results: The risk of bias was rather low. However, the methodologies of the studies were quite different. Overall, 16 articles (1 randomized clinical trial and 15 in vitro studies) were identified. The data for BPA release were reported in four articles (1 clinical trial and 3 in vitro studies). Quantitatively speaking, the amount of released BPA reported by in vitro studies was very low, if not zero. However, the BPA level was very high in the only randomized clinical trial. Many adverse effects were linked to using clear aligners or transparent retainers, including pain and soft-tissue issues such as burning, tingling, sore tongue, lip swelling, blisters, ulceration, dry mouth, periodontal problems, and even systemic problems such as difficulty in breathing. Besides these biological adverse effects, oral dysfunctions and speech difficulties and tooth damage may be associated with clear aligners and should as well be taken into consideration. Conclusion: Given the very high levels of BPA leach observed in the only clinical trial and considering other possible dangers of small traces of BPA (even at low doses) and also given the numerous adverse events linked to clear aligners or transparent retainers, it seems that safety of these appliances might be questionable and more clinical studies of biocompatibility are needed in this regard.

Efficacy of the systemic co-administration of vitamin D3 in reversing the inhibitory effects of sodium alendronate on orthodontic tooth movement: A preliminary experimental animal study.

INTRODUCTION: Bisphosphonates can severely slow down orthodontic tooth movement (OTM) by reducing bone turnover. This calls for materials and methods to reverse or neutralize their effects on OTM. We propose systemic vitamin D3 (D3) for this purpose. METHODS: Thirty-two male Wistar rats were randomized into 4 groups of 8 each. Three groups were administered D3 (3 systemic doses of 24,000 IU/kg each), alendronate (ALN) (5 doses of 7 mg/kg each), and ALN+D3 (same doses as mentioned above). One group served as the negative control. The incisors were distalized at 30 g of force for 2 weeks. OTMs were measured blindly. Radicular pressure areas were searched histologically (blindly) for capillaries, Howship's lacunae, osteoclasts, and osteoblasts. Data were analyzed statistically (α = 0.05, α = 0.0083, ß <0.1). RESULTS: OTMs in the groups D3, ALN+D3, ALN, and control were 1.900 ± 0.237, 1.629 ± 0.219, 0.975 ± 0.145, and 1.565 ± 0.324 mm (analysis of variance, P <0.001), respectively. OTM in the ALN group was smaller than all other groups (Tukey, P <0.001). OTM in the D3 group was greater than in the control group (P = 0.054). The ALN+D3 group had greater OTM than the ALN group (P <0.001) but was not significantly different from the D3 (P = 0.153) or control (P = 0.951) groups. All histologic variables were significantly different across groups (Kruskal-Wallis, P <0.001). All the markers in the D3 group were more frequent than those of the other groups (Mann-Whitney U, P <0.001). There were fewer markers in the ALN group than in the control group (P ≤0.001). The ALN+D3 group had more markers than the ALN group in terms of capillaries, osteoclasts, and osteoblasts (P ≤0.007). The ALN+D3 group was similar to the control group regarding capillaries, osteoclasts, and osteoblasts (P ≥0.382). CONCLUSIONS: Systemic vitamin D3 may accelerate OTM and increase histologic biomarkers of bone turnover. ALN reduces OTM and its histologic biomarkers. Systemic vitamin D3 can reverse this inhibitory effect of ALN on OTM back to normal.

Efficiency and side effects of a novel method for maxillary central root torque (a horizontal box loop of round wire) in comparison with the conventional rectangular wire: A finite element study.

INTRODUCTION: Applying root torque using conventional methods (rectangular wire) has side effects such as inverse and destructive forces, undesirable torque on adjacent teeth, heavy forces that are limited in range and duration, and needing too many sessions. We introduce a new method (a horizontal box loop [HBL]) that is designed to reduce many of these side effects; we tested its efficiency and side effects using finite element analysis. METHODS: An HBL was created from a 0.018-in round stainless steel archwire, in the form of an equilateral triangle of 7 mm sides, for the permanent maxillary left central incisor. As a control, a SS rectangular wire (19 × 25-in) was used. First, a pilot simulation was performed to standardize the torque in both models as 31.099 N mm. The extent of twisting by the rectangular wire, of which the same amount of moment would be applied, was estimated at 28.282°. The main study evaluated the effects of the 31.099 N.mm moments applied by both models to the left central incisor on stresses, dental movements (buccolingually, mesiodistally, and extrusive or intrusive), and intercanine or intermolar widths. RESULTS: Under standardized conditions, the HBL causes a greater palatal root torque of the central incisor than the rectangular wire. The HBL does not apply reverse root torque on adjacent teeth, whereas the rectangular wire causes reverse root torque in neighboring teeth. The HBL also causes less extrusion and expansion in the molar area than does the rectangular wire. The HBL increases intercanine width, whereas the rectangular wire might not change it. CONCLUSIONS: HBL of round wire seems an appropriate appliance and hence its clinical assessment is recommended.