Jeffrey Hillman from the
University of Florida developed a genetically modified strain of
Streptococcus mutans called BCS3-L1, that is incapable of producing
lactic acid – the acid that dissolves
tooth enamel – and aggressively replaces native flora. In laboratory tests,
rats who were given BCS3-L1 were conferred with a lifetime of protection against
S. mutans. BCS3-L1 colonizes the mouth and, compared to its native counterpart, overproduces the
lantibiotic mutacin 1140, Hillman suggested that treatment with BCS3-L1 in humans could also provide a lifetime of protection, or, at worst, require occasional re-applications. However, at this time,
no human trials were conducted. Hillman further stated that the treatment would be available in dentists' offices and "will probably cost less than $100." The product was being developed by Oragenics, but was shelved in 2014, citing regulatory concerns and patent issues. In 2016, Oragenics received a 17-year patent for the product. In 2023, the startup Lumina Probiotic began developing a BCS3-L1 application in Próspera, Honduras. In April 2024, Lumina Probiotic said it had already given the engineered strain to about 60 volunteers; this was
not a clinical trial but rather an early launch of the product; legitimate clinical trials utilize much larger sample sizes and control groups. Online pre-orders have opened with consumer kits expected to ship later that year. By January 2025 the first retail batch, 500 single-use “cosmetic toothpaste” kits priced at US $250, had been dispatched. The company now markets Lumina solely as a product that “protects enamel and balances oral pH,”
a positioning intended to keep it outside U.S. FDA drug regulations. Marketing Lumina as a 'caries vaccine' would be illegal under
FDA guidelines – making such claims would designate Lumina a class III medical device under U.S law, subjecting it to mandatory
premarket approval by the FDA. No human based
clinical trials demonstrating Lumina's efficacy as a caries vaccine were ever completed; therefore, it cannot be approved by the FDA as any form of permanent – or long lasting protection – against dental caries. Through positioning itself as a pH regulator, Lumina could be designated a class II medical device under U.S law – the same designation of products such as over the counter dental
fluoride. This designation enables Lumina to be sold without typically mandated FDA mandated clinical trials. As a result of this classification change, uninformed consumers may potentially be misled and believe the product provides full, or long lasting protection from caries, while its only FDA approved usage is as a probiotic product that protects enamel and balances oral pH. Widely available consumer products, such as
biotene, a hydrating mouthwash intended to treat dry mouth, and basic fluoride rinses are already endorsed [by the
ADA and
CDC, respectively] to address these exact concerns. In addition, uninformed consumers may simply be unaware of FDA medical device classifications and their respective regulatory obligations. They may assume Lumina is approved by the same FDA standards of a prescription drug or vaccine; in reality, it is regulated by an FDA standard intended to cover a more basic class of medical devices, such as fluoride toothpastes and denture waxes. Due to these concerns, it is reasonable to believe Lumina could be a
snake oil treatment, designed to mislead consumers who may be ill-informed. Lumina also announced plans for optional mail-in mouth-swab tests so users can check whether BCS3-L1 has stably colonised, but as of July 2025 no peer-reviewed human safety or efficacy data have been published. On rare occasions the native
S. mutans strain escapes into the blood, potentially causing dangerous heart infections. It is unclear how likely BCS3-L1 is to do the same. Another approach is being pursued by
BASF, focused on replacing native
lactobacillus flora with a variety dubbed
L. anti-caries, which prevents
S. mutans from binding to enamel. However, it is not a long-term vaccination in that no attempt is being made to have a self-sustaining population of
L. anti-caries. The intent is that the
L. anti-caries population would be frequently replenished through use of a chewing gum containing the organism. The
University of Leeds has also begun researching a recently discovered peptide known as
P11-4. When applied to a cavity and coming in contact with saliva, this peptide assembles itself in a fibrous matrix or scaffold, attracting calcium and thereby allowing the tooth to regenerate. The Swiss-based company
Credentis has licensed the peptide and launched a product called Curodont Repair in 2013. Recent studies show a positive clinical effect. ==Attempts using antibodies==