Groundbreaking Human Trial for Tooth Regeneration Drug Set To Begin

The trial aims to assess the effectiveness of an intravenous treatment for human tooth regeneration.

AP/Robert F. Bukaty
A dental hygienist examines a child. AP/Robert F. Bukaty

The first-ever clinical trial of a drug aimed at regenerating human teeth is scheduled to commence soon, following positive outcomes in animal studies.

If the trial proves successful, the innovative treatment could be commercially available by 2030. Set to take place at Kyoto University Hospital in Japan, the trial will run from September through August 2025 and involve 30 male participants aged 30 to 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, New Atlas reports. “While there has been no treatment to date providing a permanent cure, we feel that people’s expectations for tooth growth are high.”

The trial aims to assess the effectiveness of an intravenous treatment for human tooth regeneration, building on successful applications in ferrets and mice, which showed no significant side effects.

Following the initial 11-month phase, the researchers plan to expand the trial to include children aged 2 to 7 who suffer from congenital tooth deficiency — a condition that affects about 1 percent of the population and results in the absence of multiple teeth.

The research team also intends 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. Globally, the prevalence of tooth loss varies, but about 5 percent of Americans are estimated to be affected, with higher rates observed in older adults.

The drug works by deactivating the uterine sensitization-associated gene-1 (USAG-1) protein, which normally inhibits tooth growth. By blocking USAG-1’s interaction with other proteins, the treatment promotes bone morphogenetic protein signaling, which in turn stimulates new bone formation.

If the trials are successful, this therapy could become available to patients with permanently missing teeth within the next six years.


The New York Sun

© 2025 The New York Sun Company, LLC. All rights reserved.

Use of this site constitutes acceptance of our Terms of Use and Privacy Policy. The material on this site is protected by copyright law and may not be reproduced, distributed, transmitted, cached or otherwise used.

The New York Sun

Sign in or  Create a free account

or
By continuing you agree to our Privacy Policy and Terms of Use