The world’s first clinical trial of a drug designed to regenerate human teeth is slated to start in a few months, following promising results from animal studies. If successful, the revolutionary treatment could be available commercially by 2030.

Scheduled to take place at Japan’s Kyoto University Hospital, the trial will run from September through August 2025 and will involve 30 male participants ages 30-64 who are missing at least one molar. 

“We want to do something to help those who are suffering from tooth loss or absence,” said lead researcher Katsu Takahashi, head of dentistry and oral surgery at Kitano Hospital in Osaka, Japan, New Atlas reported. “While there has been no treatment to date providing a permanent cure, we feel that people’s expectations for tooth growth are high.”

The efficacy of the intravenous treatment for human teeth regeneration will be assessed, building on its successful application in ferrets and mice, which showed no significant side effects.

Following the initial 11-month phase, researchers plan to extend the trial to children ages 2-7 who suffer from congenital tooth deficiency, which results in the absence of multiple teeth. Recruitment for this Phase IIa trial is underway.

The research team also aims to broaden the scope of the trial to include individuals with partial edentulism, characterized by the loss of one to five permanent teeth due to environmental factors. The prevalence of tooth loss varies globally, but 5% of Americans are estimated to be affected, with higher rates observed in older adults.

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