RecruitingNAINTERVENTIONAL

Flapless Zygomatic Implants Robot-assisted Placement

This study is looking into a new, robot-assisted method for placing special dental implants called zygomatic implants. These implants are used when someone has lost a lot of jawbone, making it difficult to use regular dental implants. Currently, putting in these implants can be tricky, and even experienced surgeons can find it hard to get them in the perfect spot. This new approach uses a robot to guide the drilling process, aiming to make the placement more precise and potentially safer for patients. Researchers want to find out how well this robot-guided technique works and how accurate it is, hoping to improve the success of these dental procedures for people needing them.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

Start

30 Sep 2022

Estimated completion

01 Dec 2024

Zygomatic Implant Robotic

What is this study about?

This study is exploring a new way to put in a special type of dental implant called a zygomatic implant. These implants are generally used for people who have lost a lot of bone in their upper jaw, often making it impossible to fit standard dental implants. The goal of any dental implant surgery is to place the implant in the best possible position so that new teeth can be comfortably and effectively attached later on.

At the moment, placing these zygomatic implants can be quite a complex procedure, even for very skilled surgeons. Because there isn't a simple way to physically guide the drilling, the implant might not always end up exactly where the surgeon planned. This study is investigating whether using a robot can help make this process much more accurate and potentially safer.

The idea is that before the surgery, detailed scans of the patient's jaw will be used to plan the exact path for the implant. Then, during the operation, a special robot will guide the drilling tools very precisely. The final placement of the implant itself will still be done by the surgeon. By carefully checking the results, the researchers want to see if this robot-assisted technique truly improves how well these implants are positioned.

Key takeaways

This study evaluates robot-assisted zygomatic implant placement.
It aims for more precise and potentially safer surgery.
Zygomatic implants are for severe upper jawbone loss.
A robot guides drilling, but a surgeon manually places implants.
Participation helps improve future dental implant techniques.

Who may be eligible?

To be part of this study, you would need to be at least 18 years old. It's designed for people who have lost all their teeth in their upper jaw due to severe bone loss or have had part of their upper jaw removed, perhaps because of cancer or an injury, and have had reconstruction.

You wouldn't be able to join if you have ongoing sinus infections. Also, if you are pregnant or breastfeeding, this study would not be suitable for you. Importantly, you must be comfortable with the idea of a robot helping during the surgery. Taking part is always your choice, and you would need to agree to participate by signing a consent form.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Have you lost all teeth in your upper jaw due to severe bone loss?
Have you had part of your upper jaw removed (e.g., due to cancer or injury) and had it rebuilt?
Do you currently have any chronic sinus infections?
Are you pregnant or breastfeeding?
Are you comfortable with the idea of a robot assisting during the surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step involves having detailed scans of your jaw. These scans help the medical team plan the exact placement of your implants. During the surgery, a special robot will guide the drilling. The surgeon will still manually place the zygomatic implant. The study will then assess how accurate and effective this robot-assisted method is through follow-up assessments, which the study team will explain fully. The overall length of your participation would depend on these follow-up appointments.

Potential risks and benefits

Potential benefits of taking part include contributing to research that could improve dental implant surgery for many people. While robot-assisted surgery aims to increase accuracy, there are always potential risks with any surgery, such as infection or unexpected complications, which your medical team will discuss in detail. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

CHU Amiens
Verified postcode
Amiens, France· Recruiting

Common questions

What exactly is a zygomatic implant?

It's a longer dental implant that's anchored in the cheekbone (zygoma) instead of the jawbone, used when there isn't enough jawbone for regular implants.

What does 'robot-assisted' mean for my surgery?

It means a special robot will guide the surgical tools very precisely during the drilling part of your procedure, aiming for more accurate implant placement.

Will a robot be doing the entire surgery?

No, the robot guides the drilling steps, but a skilled surgeon will still be in charge and will manually place the actual implant.

Is this a new type of implant?

Zygomatic implants aren't new, but this study is testing a new way of placing them using robotic guidance.

Will I get new teeth attached after the surgery?

The study focuses on the placement of the implants, aiming to create a stable base for future dental work. Your medical team will discuss the steps for getting your new teeth.

How to find out more

Sylvie TESTELIN, Pr

sylvie.testelin@chu-amiens.fr 03.22.08.90.50 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.