A caries vaccine is a vaccine to prevent and protect against tooth decay.[1]Streptococcus mutans (S. mutans) has been identified as the major etiological agent of human dental caries. The development of a vaccine for tooth decay has been under investigation since the 1970s. In 1972, a caries vaccine was said to be in animal testing in England, and that it would have begun human testing soon.[2] Several types of vaccines are being developed at research centres, with some kind of caries vaccines being considered to diminish or prevent dental caries' impact on young people.[3]
Jeffrey Hillman from the University of Florida[4] 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.[5][non-primary source needed] BCS3-L1 colonizes the mouth and, compared to its native counterpart, overproduces the lantibiotic mutacin 1140,[5] which allows it to out-compete wild-type S. mutans.[6] 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."[7] The product was being developed by Oragenics, but was shelved in 2014, citing regulatory concerns and patent issues.[8][non-primary source needed] In 2016, Oragenics received a 17-year patent for the product.[9] In 2023, the startup Lumina Probiotic began developing a BCS3-L1 application in Próspera, Honduras.[10] In April 2024, Lantern Bioworks 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.[11]
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[12] – making such claims would designate Lumina a class III medical device under U.S law, subjecting it to mandatory premarket approval by the FDA.[13] 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[14] 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.[15] 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.[16][17] 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.[18]
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.[19]
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.[20] 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.[citation needed]
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.[21][22] The Swiss-based company Credentis has licensed the peptide and launched a product called Curodont Repair in 2013.[23] Recent studies show a positive clinical effect.[24][non-primary source needed]
Attempts using antibodies
Early attempts followed a traditional approach to vaccination where normal S. mutans was introduced to promote a reaction from the immune system, stimulating antibody production.[25][non-primary source needed]
The International Associations for Dental Research and American Association for Dental Research announced a study performed by the Chinese Academy of Sciences which looked at using an inhaled vaccine that uses a protein filament as a delivery vehicle. Trials performed in rats showed an increase in antibody response along with a decrease in the amount of Streptococcus mutans adhering to teeth, leading to significantly fewer cavities observed among the test population.[26][non-primary source needed]
DNA vaccines
DNA vaccine approaches for dental cavities have had a history of success in animal models. Dental cavity vaccines directed to key components of S. mutans colonization and enhanced by safe and effective adjuvants and optimal delivery vehicles, are likely to be forthcoming. Some believe that the rational target for developing an anti-caries vaccine is a protein antigen, which has adherent functional and important immunogenic regions.[27][clarification needed][non-primary source needed]
Bacteriophage treatment
The use of Enterococcus faecalis bacteriophages as a form of treatment for caries has been considered, as they are capable of maintaining persistent stability in human saliva.[28][non-primary source needed]
References
↑"Panel on Caries Vaccine". National Institute of Dental and Craniofacial Research of the National Institute of Health. January 28, 2003. Archived from the original on 2011-09-29. Retrieved 14 April 2008.
↑Richie, Chhabra; Karan, Rajpal (Jan 2016). "Caries vaccine: A boom for public health". Annals of Tropical Medicine and Public Health. 9 (1): 1–3. doi:10.4103/1755-6783.168715 (inactive 11 July 2025). S2CID57200550.{{cite journal}}: CS1 maint: DOI inactive as of July 2025 (link)
↑Hillman, Jeffrey D. (August 2002). "Genetically modified Streptococcus mutans for the prevention of dental caries". Antonie van Leeuwenhoek. 82 (1–4): 361–366. doi:10.1023/A:1020695902160. PMID12369203. S2CID11066428.
↑Guo, JH; Jia, R; Fan, MW; Bian, Z; Chen, Z; Peng, B (Mar 2004). "Construction and immunogenic characterization of a fusion anti-caries DNA vaccine against PAc and glucosyltransferase I of Streptococcus mutans". Journal of Dental Research. 83 (3): 266–270. doi:10.1177/154405910408300316. PMID14981132. S2CID46360161.
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