Cytotoxicity and estrogenicity of Invisalign appliances

Eliades, Theodore; Pratsinis, Harris; Athanasiou, Athanasios E.; Εliades, George; Kletsas, Dimitris

doi:10.1016/j.ajodo.2009.03.006

Cited by 64 publications

(69 citation statements)

References 18 publications

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“…However, with regard to safety considerations on the use of aligners, no similar comprehensive effort has been attempted. Sporadic reports, mainly in vitro, have examined potential cytotoxic effects of these appliances [5,6]. Recently, an in-vivo study on retainers has documented increased levels of bisphenol-A (BPA) release in saliva of patients using vacuum-formed thermoplastic adjuncts during the retention phase, compared to the use of classic Hawley-type appliances [7].…”

Section: Introductionmentioning

confidence: 99%

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

et al. 2020

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Use of thermoplastic material in orthodontics, either as aligner or as retainer appliances, is common practice and is likely to increase in the years to come. However, no systematic assessment on safety considerations of these adjuncts has been implemented up to date. The aim of this systematic review was to collectively appraise the existing evidence from both clinical and laboratory studies, on whether these appliances are associated with any estrogenic/cytotoxic effects or bisphenol-A (BPA) and monomer leaching. Eight electronic databases were searched with no limits in December 22, 2019, for published and unpublished research. Eligibility criteria comprised of studies of any design, describing use of any type of thermoplastic aligner. Study selection, data extraction and risk of bias (RoB) assessment was done independently, either in duplicate or confirmed by a second reviewer. Random effects meta-analyses of weighted mean differences (WMD) with associated 95% Confidence Intervals (CIs) were planned. Quality of the evidence was evaluated with Grading of Recommendations Assessment, Development and Evaluation (GRADE). A total of 58 articles were initially identified, while 5 were included in qualitative synthesis and 2 of those contributed to the quantitative syntheses. Four studies were in-vitro, while one was a randomized controlled trial; all assessed some type of orthodontic aligner or retainer, either as-received or retrieved. Risk of bias recordings ranged between unclear and high for all studies. Proliferation induction capacity of thermoplastic appliances’ eluents on MCF-7 cells failed to be confirmed compared to beta-estradiol (2 studies: 5% v/v, WMD: −182.08; 95% CI: −198.83, −165.33; p-value < 0.001; and 20% v/v, WMD: −184.53; 95% CI: −206.17, −162.88; p-value < 0.001). No cytotoxic activity was detected as well. In addition, although evidence from in-vitro studies was indicative of no traceable detection of BPA or other monomers, the findings from a single clinical trial were allied to increased levels of BPA in whole stimulated saliva, after up to 30 days of thermoplastic retainer usage, compared to standard Hawley retainer. The quality of the evidence overall was low to medium. Current data from in-vitro research are indicative of an absence of an estrogenic or cytotoxic effect of thermoplastic aligners or retainers. Regarding BPA or monomer release, evidence from clinical and laboratory studies appear inconsistent.

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Section: Introductionmentioning

confidence: 99%

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

et al. 2020

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“…Intraorally, these materials are exposed to extreme thermal changes, mechanical wear, pH changes, and enzymatic degradation from bacterial and salivary enzymes, which can cause BPA leaching. Previous leaching studies of orthodontic adhesives [24][25][26] and clear aligners, 27,28 which failed to investigate mechanical abrasion or temperature changes, did not observe any BPA leaching or estrogenic activity. Conversely, incomplete adhesive polymerization was shown to release BPA, 29 and adhesive particles produced during simulated debonding demonstrated estrogenic activity.…”

Section: Introductionmentioning

confidence: 99%

An investigation into bisphenol-A leaching from orthodontic materials

Kotyk¹,

Wiltshire

2013

The Angle Orthodontist

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Objective: To quantitatively determine the bisphenol-A (BPA) leached from orthodontic materials during simulated intraoral exposure. Materials and Methods: Samples of orthodontic materials were subjected to simulated abrasion, immersion in artificial saliva, thermal shock via temperature cycling, and simulated intraoral exposure. Sample aliquots were collected for up to 2 weeks after artificial saliva immersion, derivatized, then analyzed for BPA by gas chromatography/mass spectroscopy. Results: Quantifiable amounts of leached BPA were observed from a thermoformed orthodontic retainer material (7.63 mg/g of material) and an orthodontic adhesive (2.75 mg/g of material). BPA leaching was only observed within the first 3 days of artificial saliva immersion. Conclusions: Under the test conditions, BPA was observed to leach from two orthodontic materials. While the quantities of leached BPA were below the reference dose for daily intake, existing data of low-dose effects and medical disorders associated with elevated urinary BPA levels suggest that BPA exposure, and thus the use of the leaching materials identified in this study, should be reduced or eliminated. (Angle Orthod. 2014;84:516-520.)

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“…Since the aligner is removable, patients' daily oral hygiene routines are not impeded. The safety of Invisalign aligners to gingival epithelial cells has also been validated in vitro (Eliades, Pratsinis, Athanasiou, Eliades, & Kletsas, 2009;Premaraj, Simet, Beatty, & Premaraj, 2014).…”

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The dynamics of the oral microbiome and oral health among patients receiving clear aligner orthodontic treatment

et al. 2020

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Objectives This 6‐month prospective clinical study assessed the impacts of Invisalign appliances on the oral bacterial community and oral health of patients. Methods Salivary samples were obtained from twenty‐five adult patients receiving Invisalign aligner treatment before the treatment (Group B) and at a 6‐month follow‐up (Group P). The bacterial composition of each sample was determined using Illumina MiSeq sequencing of the bacterial 16S rRNA. Intra‐ and intergroup biodiversity was analyzed. Clinical periodontal parameters and daily oral hygiene habits were recorded. Results Reduction in plaque, increased daily brushing frequency, and decreased dessert intake were observed in Group P compared with that in Group B. A total of 1,853,952 valid reads were obtained from the 50 salivary samples, with 37,904 sequences per sample. No significant differences were detected in the intra‐ and intergroup biodiversity comparisons between the two groups. By clustering, 8,885 OTUs were identified and categorized into six major phyla: Firmicutes, Proteobacteria, Bacteroidetes, Fusobacteria, Actinobacteria, and Candidate_division_TM7_norank. At the genus level, compared with Group B, Group P demonstrated significantly increased Bacillus abundance and decreased Prevotella abundance. Conclusions Our results suggested that the general biodiversity and salivary microbial community structure did not change significantly and that patients had increased beneficial oral hygiene habits and awareness during the first six months of Invisalign treatment. Hence, on the basis of this study, it appears that Invisalign aligner treatment did not induce deterioration of oral health nor significant biodiversity changes in oral bacterial communities, assuming that detailed oral hygiene instructions for both teeth and aligners were provided.

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Cytotoxicity and estrogenicity of Invisalign appliances

Cited by 64 publications

References 18 publications

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

An investigation into bisphenol-A leaching from orthodontic materials

The dynamics of the oral microbiome and oral health among patients receiving clear aligner orthodontic treatment

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