Q＆A
～Clinical trial-related matters～
- When does the clinical trial start?
- The P1 trial has already been completed, having started in February 2024.
The P2 trial is scheduled to begin in fiscal year 2025. - Are the subjects of the clinical trial specifically determined?
- To some extent, the selection of subjects has already been decided.
*Please refer to the section 'What is a clinical trial?' under 'About research.' - Can people other than those with congenital tooth agenesis participate in clinical trials?
- Currently, only those diagnosed with congenital tooth agenesis are eligible.
- Can people who have lost teeth due to cavities, extractions, or accidents participate in the clinical trial?
- The current study is aimed at developing a treatment medication for those born with missing teeth, so participation by anyone outside the target group is not possible.
- Can I participate in a clinical trial if I live overseas?
- Currently, we are focusing on obtaining approval within Japan and are not handling overseas requirements
at this time.
Once approval is granted in Japan, we will consider handling overseas requirements in the future. - Can I participate in a clinical trial if I go to Japan?
- Due to various regulations and rules for conducting clinical trials, you cannot participate even if you come to Japan.
- Will the results of the clinical trial be made public?
- We conduct various clinical trials before a treatment medication is completed, but since the results of the clinical trials are important data until the medication is completed, we do not disclose the results.
～About medicine (therapeutic medicine)～
- When will a treatment be available?
- Our goal is to make it available in Japan as a regenerative medicine medication by 2030.
- Can I still get treatment through orthodontics or implants?
-
It is possible that tooth buds will disappear if you undergo orthodontic or implant treatment, but the
extent to
which such treatment will have a difference in effect from person to person, and a judgement can only be
made
after the treatment medication is completed and prescribed to more people, so we cannot answer at this
time.
We recommend that you consult thoroughly with your dentist and receive the best treatment available at this time. - Are there any side effects from the medication?
- We conduct safety confirmation tests during the development stage of the treatment medication, but because there are individual differences, we cannot answer at this time because we cannot make a judgment on the results until the treatment medication is completed and prescribed to many more people.
- Will the finished treatment be available to buy at pharmacies?
- The therapeutic medication will be prescribed as a prescription medication after a diagnosis has been made at a medical examination, so it cannot be purchased at a pharmacy.
～Other～
- Can I ask questions over the phone?
- Our therapeutic medication therapeutic medication research group does not have staff dedicated to answering the phone, and in order to provide accurate answers, we do not respond to phone calls.
- Can I participate in the development of therapeutic medications itself?
- Since therapeutic medication research and development of therapeutic medications has been conducted from the beginning through collaboration between various domestic organizations among industry, government, and academia, we are currently declining all requests for participation in therapeutic medication research and development of therapeutic medications.
- Can I contact the principal investigator, Dr. Takahashi, directly?
-
As this is personal information, we cannot provide contact information.
Please note that we will also be unable to respond to requests for Dr. Takahashi to contact you.
For interview requests, please contact us via the Kitano Hospital website URL below.
https://www.kitano-hp.or.jp/contact/shuzai - Can we request that Dr. Takahashi, the principal investigator, give a seminar or lecture?
- We are very sorry, but we are not currently accepting orders.
- Can you fund therapeutic medication research?
- Please refer to the URL below.
Donations can be made to cover the costs of Dr. Takahashi's personal research into therapeutic medications. - If there is any new information, could you please contact me individually?
- Due to the large number of inquiries we receive from all over the world, we do not send out individual announcements or e-mail newsletters.
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