Japanese research aims to make new teeth grow in adults.

The idea of growing a new tooth in adults — something that until recently seemed like science fiction — is becoming a real possibility thanks to a clinical study conducted in Japan .

Japanese flag, Mount Fuji, and cherry blossoms.

Unlike reptiles and fish, which generally replace their prey regularly, it is widely accepted that humans and most other mammals develop only two sets of teeth.

According to the research, hidden beneath our gums are the dormant buds of a third generation.

The research, which has officially entered the human testing phase, promises to usher in a new era in regenerative dentistry, offering a biological alternative to dental implants.

Instead of replacing the lost tooth with artificial materials, the goal is to stimulate the body itself to produce a new tooth, as if we were regaining the natural ability to "replace" teeth throughout life.

The study is being conducted at Kyoto University Hospital , one of Japan's most respected medical centers, known for its strong performance in advanced clinical research.

The project is being led by Dr. Katsu Takahashi , an oral and maxillofacial surgeon and head of Oral Surgery at the Medical Research Institute Kitano Hospital in Osaka.

Takahashi is internationally recognized as one of the pioneers of dental regeneration , and his research group has been investigating the biological mechanisms that control tooth development for years.

The central innovation of the study is the drug TRG-035 , a monoclonal antibody administered intravenously . It works by blocking the USAG-1 protein, which acts as a natural "brake" on the growth of additional teeth.

Before moving on to human trials, researchers conducted extensive tests on mice and ferrets to test the efficacy and safety of TRG-035.

Tests have shown that by inhibiting this protein, dormant tooth buds can be activated, resulting in the growth of a new, complete tooth—with root, enamel, and functional structure. These encouraging results led to the creation of a Japanese biotechnology startup dedicated to transforming the discovery into a clinical treatment.

Clinical trials began in October 2024 , following ethical approval in Japan, although the exact date of the approval has not been publicly disclosed.

The current phase, called phase I , involves 30 adult men between 30 and 64 years old , all with at least one missing tooth. The objective of this phase is not to prove efficacy, but rather to evaluate the safety of the medication, its tolerability, and the appropriate dosage.

To date, there are no reports of people who have regenerated teeth — this will be investigated in subsequent phases, should phase I confirm that the treatment is safe.

Preclinical results are quite promising. In animals, TRG-035 induced the growth of functional teeth without serious side effects.

The consistency of the results, coupled with the fact that similar antibodies are already safely used in osteoporosis treatments, reinforces the researchers' confidence in continuing the study.

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International experts, such as Professor Angray Kang of Queen Mary University of London, state that the Japanese group is "leading the way" and that the approach is "plausible and promising," but it is not a "short race," as it involves successive "ultramarathons."

Chengfei Zhang , a clinical professor of endodontics at the University of Hong Kong, commented that the method is "innovative and has potential," but urged caution, citing that results from animal studies do not always directly apply to humans. He also questioned whether the newly grown teeth could match the functionality and appearance of natural teeth.

A confident Takahashi argues that the location of a new tooth in the mouth can be controlled, if not precisely determined, by the injection site of the medication. And if it grows in the wrong place, it can be moved through orthodontics or transplantation, he said.

It is not yet known how long it will take for a new tooth to appear in humans after administration of the drug. In animals, the process took weeks to months, but in humans—whose tooth formation is slower—a longer interval is expected, possibly from several months to more than a year.

Potential risks, such as interference with bone signaling pathways or tooth growth in unexpected positions, remain under evaluation, although none of this has been observed in animal models so far.

The total investment in the project has not been disclosed by international sources, but it is known that the development involves a partnership between Japanese universities and a biotechnology startup, indicating mixed public and private funding. To date, there are no formal partnerships with foreign companies or research centers from other countries, although international interest is growing.

The state of the art is clear: Japan is currently the only country with an active clinical trial for tooth regeneration using antibodies. The United States, Europe, and China are following the progress, but do not yet have equivalent clinical studies. If the next phases confirm safety and efficacy, the treatment could usher in a new era in dentistry, offering a biological alternative to dental implants and benefiting millions of people with tooth loss or congenital conditions.

The Japanese study on the “third set of teeth” represents one of the most exciting frontiers in regenerative medicine. Although still in its early stages and far from becoming a publicly available treatment, it already demonstrates the potential to radically transform how we treat tooth loss.

Science still needs to answer many questions, but the path opened by Dr. Takahashi and his team presents the world with an unprecedented possibility: recovering lost teeth not with prostheses, but with human biology itself.

By Luiz Cincurá.

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Sources:

CLEVELAND 13 NEWS. PORTIER, Lauren. Japanese Scientists Begin Human Trials for Tooth Regrowth Drug with Goal of 2030 Release. Available at: <https://www.cleveland13news.com/ > Accessed on: December 21, 2025.

LUMINANCE DENTAIRE. GABEV, Angel. Japanese Scientists Begin Human Trials for Tooth Regrowth Drug. Available at : <https://luminancedentaire.ca/> Accessed on: December 21, 2025.

MEDICAL XPRESS . A news report about the start of clinical trials and details of the study with TRG‑035. Available at: <https://medicalxpress.com/> Accessed on: 21.dec.2025.