In a groundbreaking development, the world’s first human trial of a drug designed to regenerate teeth will commence in September at Kyoto University Hospital. This marks a significant leap from the drug’s initial success in animal models, potentially making it commercially available by 2030.
The trial will involve 30 men aged 30 to 64 who are missing at least one molar. Over an 11-month period, the intravenous treatment will be evaluated for its effectiveness in human dental regeneration. Previous trials on ferrets and mice showed successful tooth regrowth without significant side effects. Lead researcher Katsu Takahashi, head of dentistry and oral surgery at Kitano Hospital, stated, “We want to do something to help those who are suffering from tooth loss or absence. While there has been no treatment to date providing a permanent cure, we feel that people’s expectations for tooth growth are high.”
Following this initial phase, the research team plans to trial the drug on children aged 2 to 7 who have congenital tooth deficiency, a condition affecting approximately 1% of the population. Recruitment for this Phase IIa trial is currently underway.
Future plans include expanding the trial to individuals with partial edentulism, or those missing one to five permanent teeth due to environmental factors. In the United States, around 5% of the population is affected by tooth loss, with higher rates among older adults.
The drug works by deactivating the uterine sensitization-associated gene-1 (USAG-1) protein, which normally suppresses tooth growth. By blocking USAG-1, bone morphogenetic protein (BMP) signaling is encouraged, leading to the generation of new bone and the emergence of new teeth. The USAG-1 protein exhibits a high amino acid homology of 97% across various species, including humans, mice, and beagles. However, a beagle trial has yet to be announced.
Takahashi, a molecular biologist and dentist, has dedicated his research to tooth regeneration since 2005. He envisions this treatment benefiting not only those with congenital dental conditions but anyone who has lost teeth at any age. This pioneering approach promises to revolutionize dental care and provide a permanent solution to tooth loss.
