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Study on the Effect of Methylprednisolone Injection for Reducing Swelling, Stiffness, and Pain After Lower Wisdom Tooth Surgery in Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding the effects of a medication called methylprednisolone hemisuccinate on the recovery process after surgery to remove lower wisdom teeth, also known as third molars. The study aims to see how this medication, when injected into the muscle before surgery, can help reduce common post-surgery issues such as swelling, difficulty opening the mouth (known as trismus), and pain.

The trial involves a comparison between the effects of methylprednisolone and a placebo. Participants will receive an injection of either the medication or a placebo before their surgery. The study is designed to be randomized and double-blinded, meaning neither the participants nor the researchers will know who receives the actual medication or the placebo, ensuring unbiased results.

The purpose of this study is to investigate whether using methylprednisolone can improve recovery after wisdom tooth surgery. Participants will be monitored for changes in swelling, trismus, and pain following their procedure. This research could provide valuable insights into better managing post-operative symptoms and improving patient comfort after dental surgeries.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
An initial assessment is conducted to confirm eligibility for the study. Eligibility criteria include having lower wisdom teeth on both sides in a similar position, being between 18 and 50 years old, being healthy, not taking any medication that could affect the treatment, and maintaining good oral hygiene.
Step 2
Preoperative preparation
Before the surgery, an injection of methylprednisolone hemisuccinate is administered. This is a corticosteroid given as a solution for injection to help reduce swelling, trismus (difficulty opening the mouth), and pain after the surgery.
Step 3
Surgery
The surgery involves the removal of the lower third molars (wisdom teeth). This step is performed under standard surgical procedures.
Step 4
Postoperative monitoring
After the surgery, monitoring is conducted to assess the effects of the corticosteroid injection on postoperative symptoms such as swelling, trismus, and pain.
Step 5
Follow-up evaluations
Follow-up evaluations are scheduled to continue monitoring recovery and to gather data on the effectiveness of the treatment. These evaluations help in understanding the impact of the preoperative injection on postoperative recovery.

Who can join the trial?

8 criteria

Must have lower wisdom teeth on both sides of the mouth.
The wisdom teeth should be deeply impacted, meaning they are stuck in the jaw and not fully visible.
The position of the wisdom teeth should be similar on both sides.
Age must be between 18 and 50 years old.
Must be in good health overall.
Should not be taking any medication that could affect the treatment.
Must have good oral hygiene, meaning the mouth and teeth are clean and well-cared for.
Both males and females can participate.

Who cannot join the trial?

4 criteria

Individuals who are not experiencing any issues after surgery, known as postoperative sequelae, cannot participate.
People who are not within the specified age range for the study cannot join. The exact age range is not provided here.
Participants must be either male or female, as both genders are included in the study.
Individuals who are considered part of a vulnerable population, meaning they might need special protection or care, are not allowed to participate.

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Semmelweis University
Budapest, Hungary

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Investigated drugs

Methylprednisolone is a corticosteroid medication used in this trial. It is injected into the masseter muscle before surgery to help reduce swelling, pain, and difficulty opening the mouth (trismus) after the removal of a lower third molar, commonly known as a wisdom tooth. This medication works by decreasing inflammation and the body's immune response, which can help improve recovery after surgery.

Methylprednisolone Hemisuccinate

What is already known about the treatment

Methylprednisolone – This medication is administered as an injection directly into the masseter muscle. It is currently being studied in clinical trials to assess its effectiveness in reducing post-operative swelling, limited mouth opening, and pain following lower third molar surgery. Methylprednisolone is a corticosteroid, which works by suppressing inflammation and the immune response at the molecular level. It is classified pharmacologically as a glucocorticoid.

Investigated diseases

Postoperative Sequelae – This condition refers to the complications or symptoms that occur after a surgical procedure. It can include a range of issues such as swelling, pain, and limited movement in the affected area. These symptoms are common following surgeries, especially those involving the removal of impacted teeth like the lower third molars. The severity and duration of these symptoms can vary depending on the individual and the complexity of the surgery. Postoperative sequelae are generally temporary and tend to improve as the healing process progresses.