Skip Ribbon Commands
Skip to main content

3D-Printed Dental Plug: FAQ

About the clinical study
Helping to test new ways of medical treatments

The Ministry of Health, Singapore requires pharmaceutical manufacturers to conduct clinical studies consisting of rigorous tests that demonstrate the safety and effectiveness of a new treatment before it is approved for use.

There are many different types of clinical studies. Our clinical study is a prospective, non-blinded and controlled clinical trial for patients requiring single tooth extraction, and who are suitable for dental implant treatment after extraction.

If you are eligible to participate in the study, you will be randomly allocated to a test group or control group. You cannot choose which group you will be allocated to. Participants in the test group will receive a 3D-printed PCL-TCP dental plug as a space-filler after tooth extraction, while participants in the control group will have no space filler after tooth extraction.

It is important that you understand what the clinical study is about, the potential risks, and what is needed from you before you agree to take part. We hope the information on this website will help you to make an informed decision on participating in this clinical study.

You do not need to take part in this clinical study to receive a dental implant after your tooth extraction. Please speak with your dentist to discuss available treatment options.

Potential benefits and risks of taking part in the clinical study

There is no guarantee that you will receive any direct benefit from taking part in the clinical study. Potential benefits from your participation include:

  • The development of a new device for dental implant that may benefit others in the future
  • Your condition will be monitored by our team of dental specialists throughout the study
  • Charges for the following will be waived for trial participants:
    • 3D-printed dental plug
    • Dental implant fixture
    • Surgery

*Fees for crown treatment will apply

As with all medical treatments, there may be risks associated with the treatments involved in a clinical study. Our team will discuss these risks with you at National Dental Centre Singapore, prior to your participation.

Your involvement in the study

It will include a minimum of 10 visits to the study dentist (Visit 1 to Visit 10) throughout a 12-month duration.

During the study, you will be randomly assigned to either the test or control group.

You cannot choose which group you will be allocated to. Participants in the test group will receive a 3D-printed PCL-TCP dental plug as a space-filler after tooth extraction, while participants in the control group will have no space filler after tooth extraction.

During the study visits, several tests and assessment will be carried out, including but not limited to:

  • X-rays to view the dental structure as part of routine care. Estimated radiation exposure of each radiograph is less than 0.0083 mSv
  • Cone Beam Computed Tomography (CBCT) scan, a medical imaging technique using X-rays to accurately visualise teeth orientation and structures
  • Coring, a process where a small portion of the bone in the jaw ridge is removed. This is a standard routine to an implant surgery


How much will it cost?

Surgical fees and cost of implant materials will be waived for trial participants. However, you will have to bear the costs of consultation, consumables and crown restoration.


What else do I need to consider?

Our team will fully explain the potential risks and benefits of joining this clinical study. There is a possibility that your condition will improve, stay the same or worsen during this clinical study. Nevertheless, information gathered from this clinical study can help further our knowledge of alveolar bone preservation, which may benefit those who need it in the future.

 
What if I change my mind and no longer wish to participate?

Participation in the study is voluntary, and you can leave the study at any time. Please inform our team if you decide to withdraw from the study. You may need to undergo some final tests and procedures prior to your withdrawal.