Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Randomised, double-blind study comparing the analgesic efficacy of a lidocaine-prilocaine combination with lidocaine alone as local anesthesia for dental procedures in participants with MC1R mutation

This study is investigating how well different numbing medications work during dental procedures. Specifically, it's comparing a combination of two common numbing medicines, lidocaine and prilocaine, with lidocaine used on its own. The main goal is to find out which option is better at making sure your tooth nerve is completely numb, so you don't feel any pain during your dental treatment. Researchers will check this by using a special tool to see if the tooth nerve responds and by asking participants about their comfort. They also want to understand how comfortable patients feel using these different numbing injections. This research could help dentists choose the best numbing medicine for their patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pharmavax AS

Enrolment target

Start

27 Nov 2024

Subjects having local anesthesia for dental procedures.

What is this study about?

Imagine going to the dentist for a filling or other treatment, and you need your tooth to be completely numb so you don't feel any discomfort. This study is all about finding the best way to do that. Researchers are looking at two different types of numbing shots, also known as local anaesthetics.

One numbing shot is a combination of two medicines: lidocaine and prilocaine. The other shot contains just lidocaine. Both are commonly used to numb parts of your mouth before dental work. The aim is to see if combining lidocaine with prilocaine works better at making your tooth completely numb compared to using lidocaine by itself. This is important because fully numb teeth mean a much more comfortable experience for you at the dentist.

The study will carefully measure how effective each numbing shot is. They'll check if the tooth nerve is truly asleep and not responding to any stimulation, and they'll also ask you about your experience to understand how well you felt the numbing worked in your gums and soft tissues.

Key takeaways

This study compares two numbing injections for dental work.
It aims to find the most effective way to numb your tooth.
Participants will receive standard dental numbing.
You'll be asked about your comfort during the procedure.
The study helps improve future dental pain relief.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages are welcome.

This study is open to both men and women. If you are having a dental procedure that requires a numbing injection, you might be suitable for this study.

It's important to remember that these are just general guidelines. The study team will review your medical history and specific dental needs to confirm if you are a good fit for the study.

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 18 years old or older?
Are you having a dental procedure that needs a numbing injection?
Are you comfortable with the dentist checking how well your tooth is numb?
Are you able to rate your comfort on a scale?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive one of the two numbing injections before your routine dental procedure. You won't know which one you're getting, and neither will your dentist at the time of injection – this helps make the study fair. During and after the injection, the study team will use a special device called an electric pulp tester to check if your tooth nerve is completely numb. They will also ask you to report if you feel any cold sensation during a test and how well you think your gums and soft tissues are numb. You'll also be asked to rate your overall experience of the anaesthesia on a simple scale. All of these checks will happen during your regular dental visit. There are no extra visits or follow-up appointments specifically for the study. The total duration of your participation would only be the time spent during your dental appointment.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to our understanding of the most effective numbing medicines for dental procedures, which could improve comfort for future patients. The risks associated with the numbing injections are those commonly experienced with dental local anaesthetics, such as temporary numbness, a brief sting during injection, or rarely, a temporary feeling of your heart beating faster (which usually passes quickly). You can choose to stop participating in the study at any time, for any reason, without it affecting your dental care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Norway

Common questions

What is 'numbing medicine'?

It's a special medicine injected into your gum to temporarily stop you from feeling pain during dental work, also called a local anaesthetic.

What's the difference between the two numbing medicines?

One is a mix of two common numbing agents, lidocaine and prilocaine. The other is just lidocaine, which is also very common.

Will I feel pain if the numbing doesn't work fully?

The dental team will ensure you are comfortably numb before starting your procedure. Your comfort is their priority.

How long will this study add to my dental appointment?

Any extra time for the study measurements will be very minimal and happen during your regular appointment.

Can I still get my dental work done if I don't join the study?

Yes, your decision about the study will not affect your dental treatment in any way.