Key Points

• RD Dental Clinic (Director: Misako Nakashima, Location: Kobe City, Hyogo Prefecture), part of the Medical Corporation Kenkō Mirai, began recruiting patients for a clinical study evaluating the safety of pulp regeneration treatment using allogeneic dental pulp stem cells, the first of its kind in Japan, on January 28, 2025.
• In the "Autologous Dental Pulp Regeneration Treatment" introduced in 2020, tooth extraction (such as from baby teeth or wisdom teeth) was required for stem cell collection. However, the results of this clinical study could potentially allow patients without such teeth to receive pulp regeneration treatment.

What is Pulp Regeneration Treatment?

Pulp regeneration treatment is a regenerative medical procedure that involves transplanting dental pulp stem cells (obtained from teeth that are not used for biting, such as wisdom teeth) into the root canal of a tooth (called a "receptive tooth") where the dental pulp has been lost due to severe cavities or trauma. The goal is to regenerate the lost pulp and restore the tooth’s health.

The dental pulp, located at the center of the tooth, contains not only nerves but also blood vessels and lymphatic vessels. It plays an essential role in maintaining a healthy tooth by supplying moisture and nutrients, preventing bacterial invasion, and repairing the tooth’s hard tissue (dentin).

Pulp regeneration treatment aims to regenerate lost dental pulp to extend the lifespan of one’s natural teeth. The widespread use of this treatment could contribute to an extended healthy lifespan and the realization of a long-lived, healthy society by helping more people maintain their natural teeth for life.

Differences Between Regular Dental Treatments and Pulp Regeneration Treatment

When a cavity reaches the dental pulp, it causes inflammation, resulting in symptoms like "sensitivity" or "pain." It is estimated that around 5 million teeth per year lose their pulp due to such inflammation.

In regular dental treatments, the inflamed pulp is completely removed (a procedure called "pulpotomy"), and the root canal is sealed with an artificial material. As of now, about 60 million such treated teeth exist, with around 1 million teeth each year being extracted due to poor prognosis. When the pulp is lost, the tooth’s ability to supply moisture, nutrients, resist bacteria, and repair dentin is diminished, making the tooth more vulnerable to cracking or breaking.

In pulp regeneration treatment, instead of using artificial materials, "dental pulp stem cells," which have a high ability to regenerate nerves and blood vessels, are transplanted into the root canal. This process promotes the regeneration of dental pulp, restoring its vital functions, and can help the tooth last longer and remain healthier.

Advantages of Allogeneic Pulp Regeneration Treatment Compared to Autologous Pulp Regeneration Treatment

The "Autologous Pulp Regeneration Treatment" involves harvesting and cultivating dental pulp stem cells from the patient’s own teeth (such as baby teeth or wisdom teeth) and transplanting them into another tooth that has lost its pulp. This treatment was commercialized in 2020 and is currently offered at 27 dental clinics nationwide (as of January 2025).

Although the success rate for this treatment is around 90%, it requires the patient to have spare teeth, which is a limitation. For patients over the age of 45, approximately 80% of them do not have unused teeth suitable for this procedure.

However, in the current situation, around 5 million teeth are extracted each year due to dental treatment, many of which still contain viable dental pulp stem cells. If these allogeneic pulp stem cells from extracted teeth can be utilized for "allogeneic pulp regeneration treatment," it would allow patients without unused teeth to regenerate their pulp and reduce the physical and mental burden caused by the need for tooth extraction.

Flow of Allogeneic Pulp Regeneration Treatment

In allogeneic pulp regeneration treatment, dental pulp stem cells from a donor (a person providing the cells) are transplanted into the root canal of the recipient's tooth after cleaning and sterilization.

Overview of the Clinical Study

• Study Name:
  Pulp Regeneration Treatment Using Allogeneic Dental Pulp Stem Cells After Root Canal Treatment
• Objective:
  To evaluate the safety of pulp regeneration using allogeneic dental pulp stem cells.
• Implementing Facility:
  Medical Corporation Kenkō Mirai RD Dental Clinic
• Target Patients:
  Patients with irreversible pulpitis or apical periodontitis (10 cases planned)
• Method:
  Allogeneic pulp regeneration treatment will be conducted by transplanting pulp stem cells harvested and cultured from donor teeth into the root canal of the recipient's affected tooth. The safety of the procedure will be assessed.
• Specific Cell Processing Manufacturer:
  Aeras Bio Inc.
• Implementation System:
  Administrator: Misako Nakashima
  Principal Investigator: Misako Nakashima
  Full-time Dentist: Haruyoshi Sasaki
  Part-time Dentists: 7 others

Comments from Related Parties

• Misako Nakashima, Director of RD Dental Clinic:
  "It has been 4 and a half years since we began autologous pulp regeneration treatment at RD Dental Clinic, and the safety of using autologous dental pulp stem cells has been confirmed. If this study confirms the safety of allogeneic pulp regeneration treatment, many patients who previously could not receive treatment due to a lack of unused teeth will now have the opportunity to do so."

About RD Dental Clinic

"Our wish is to contribute to a healthy, long-lived society by enabling people to live happily and actively through the joy of eating with their own teeth." At our clinic, we are dedicated to helping every patient cherish and protect their natural teeth and enjoy a fulfilling life with healthy teeth, through the practical use and widespread adoption of pulp regeneration treatment.

Inquiries about this Clinical Study

For inquiries regarding this clinical study, please contact:
Medical Corporation Kenkō Mirai RD Dental Clinic
Contact Form: https://www.rdshikaclinic.com/contact/
1-3-1 Minamimachi, Port Island, Chūō-ku, Kobe City, Hyogo International Advanced Medical Center Kobe 4F
Website: https://www.rdshikaclinic.com/