Bisphenol-A release from thermoplastic clear aligner materials: A systematic review.

Area of Science:

• Biomaterials Science
• Dental Materials
• Toxicology

Background:

• Assessing the potential leaching of bisphenol-A (BPA) from thermoplastic materials used in clear aligners (CA) is crucial for patient safety.
• Existing research presents conflicting findings regarding BPA release, necessitating a comprehensive review of the evidence.

Approach:

• A systematic review was conducted, searching multiple electronic databases for in vivo and in vitro studies up to October 2022.
• Six studies (one RCT, five in vitro) were included, with risk of bias and evidence quality assessed using established tools.

Key Points:

• Only two of the six included studies reported BPA leaching from clear aligner materials.
• The risk of bias was generally moderate to high, and the GRADE evidence level was low to very low.
• Significant heterogeneity among studies precluded a quantitative synthesis of the data.

Conclusions:

• Current evidence is insufficient to confirm or deny BPA release from clear aligners.
• The safety of clear aligners concerning BPA exposure remains questionable pending high-quality in vivo research.