AuthorisedTherapeutic use (Phase IV)Interventional

Effect of preoperative intramasseteric methylprednisolone injection on the post-operative sequelae of lower third molar surgery: a placebo controlled, randomized, double-blinded study

This research study is investigating if a special steroid injection, called methylprednisolone, given into the jaw muscle just before having a lower wisdom tooth removed, can help manage the discomfort you might experience afterwards. Many people have wisdom teeth removed, and this often leads to some pain, swelling, and difficulty opening the mouth. The study is comparing the steroid injection to a 'dummy' injection (placebo) that contains no active medicine, to see if the steroid can significantly reduce these common side effects. By doing this, researchers hope to find a better way to make recovery from wisdom tooth surgery more comfortable for patients. Participants will be adults, and neither they nor their doctors will know whether they're receiving the actual steroid or the dummy injection.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Semmelweis University

Enrolment target

Start

15 Jan 2025

postoperative sequalae

What is this study about?

When you have a lower wisdom tooth taken out, it's very common to experience some side effects like pain, swelling, and finding it hard to open your mouth wide. These effects can make the first few days after surgery quite uncomfortable. Doctors are always looking for ways to make this recovery easier for patients.

This study is trying to find out if a common medicine called methylprednisolone, which is a type of steroid often used to reduce swelling, can help. The idea is to give a small injection of this steroid directly into the jaw muscle before the surgery starts. The researchers want to see if this 'pre-emptive strike' can reduce the amount of pain and swelling you experience, and help you get back to normal more quickly after the operation.

This is a 'Phase IV' study, which means the medicine being tested (methylprednisolone) is already approved and used for other conditions. The study is specifically looking at a new way to use it for wisdom tooth removal. By comparing it to a 'dummy' injection (which looks the same but contains no active medicine), the researchers can accurately tell if the steroid is genuinely making a difference or if the improvements are due to other factors.

Key takeaways

This study investigates if a steroid injection before wisdom tooth removal reduces pain and swelling.
It compares an active steroid (methylprednisolone) to a dummy injection.
The steroid is already used for other conditions; this is a new way to use it.
Participation involves an injection, surgery, and follow-up to track recovery.
You won't know if you received the steroid or the dummy injection.
The goal is a more comfortable recovery after wisdom tooth surgery.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. The study welcomes both men and women.

The main focus is on people who are scheduled to have a lower wisdom tooth removed. This is because the study specifically looks at the effects of the injection during and after this particular type of dental surgery.

There might be other specific health requirements or conditions that would prevent someone from joining, which the study doctors would discuss with you. They will check your medical history to make sure the study is safe and right for you.

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 scheduled to have a lower wisdom tooth removed?
Are you comfortable with receiving an injection into your jaw muscle?
Are you willing to attend follow-up appointments after your surgery?
Do you understand that you might receive a dummy injection instead of the active medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a meeting with the study team to understand everything and ask any questions. If you agree, you'll sign a consent form. Before your wisdom tooth surgery, you would receive an injection into your jaw muscle. You won't know if this is the active steroid medicine or a dummy injection, and neither will your doctor.

After your surgery, the study team will ask you to report on your pain levels, swelling, and how easily you can open your mouth over a certain period. This might involve filling out questionnaires or having measurements taken during a few follow-up visits. The total duration of your participation will depend on how long the study needs to track your recovery after surgery.

Potential risks and benefits

Taking part might offer the potential benefit of a more comfortable recovery from your wisdom tooth surgery if you receive the active steroid. However, there's also a chance you might receive the dummy injection and experience the usual post-surgery discomfort. Like any medicine, the steroid injection could have side effects, though these are typically mild and temporary, such as a little soreness at the injection site. All medical procedures carry some risks, and the study team will explain these fully. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Hungary

Common questions

What is a 'dummy' injection?

A 'dummy' injection, also called a placebo, looks exactly like the real medicine but doesn't contain any active drug. It helps researchers see if the medicine itself is causing an effect, or if improvements might be due to other things.

Is methylprednisolone new?

No, methylprednisolone is a steroid medicine that's been around for a while and is used for many different conditions. This study is testing a new way to use it for wisdom tooth surgery.

Will I know if I got the real medicine?

No, during the study, neither you nor your doctor will know if you received the active steroid or the dummy injection. This helps ensure the study results are fair and accurate.

What if I experience side effects after the injection?

The study team will monitor you closely. If you experience any side effects, you should tell them immediately. They are there to support you and ensure your safety.

Do I have to pay to join the study?

No, taking part in a clinical study is typically free for the participant. All study-related treatments and tests are usually covered by the research study itself.