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Study on the Effectiveness of Dexamethasone for Reducing Swelling, Pain, and Jaw Stiffness in Patients Undergoing Wisdom Tooth Extraction

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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 the surgical removal of impacted lower third molars, commonly known as wisdom teeth. The study aims to evaluate the effectiveness of a medication called dexamethasone in reducing swelling, limited mouth opening, and pain associated with this type of dental surgery. Dexamethasone is a medication that helps reduce inflammation and is being tested in two forms: an oral solution and a solution for injection.

The purpose of the study is to compare the effects of dexamethasone when applied in two different ways: orally, which means taking it by mouth, and through an injection into the masseter muscle, which is a muscle in the jaw. Both methods of application will be done immediately before the surgical procedure. The study will help determine which method is more effective in managing the common symptoms that occur after wisdom tooth extraction.

Participants in the study will receive either the oral or injectable form of dexamethasone, or a placebo, before their surgery. The study will follow participants for up to one year to monitor their recovery and assess the effectiveness of the treatment. This research will provide valuable insights into the best ways to manage discomfort and improve recovery after wisdom tooth surgery.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of both lower molars in conditions of intraosseous retention, age between 18 and 40 years, and a systemic status compatible with ASA I classification.

    It is important that no anti-inflammatory treatment has been received for at least 30 days before the surgery.

  2. Step 2

    Informed consent

    Signing an informed consent form is required to participate in the study. This document outlines the details of the trial and confirms voluntary participation.

  3. Step 3

    Preoperative medication administration

    Dexamethasone is administered immediately before the surgical procedure. The medication can be applied either orally or through a local injection into the masseter muscle.

    The choice of administration route is determined as part of the study protocol.

  4. Step 4

    Surgical procedure

    The surgical procedure involves the extraction of retained lower third molars. This is performed following the administration of dexamethasone.

  5. Step 5

    Postoperative follow-up

    Follow-up assessments are conducted to evaluate the effectiveness of dexamethasone in reducing swelling, limited mouth opening, and pain after surgery.

    The primary endpoint of the study is a one-year follow-up to monitor the outcomes of the treatment.

Who can join the trial?

7 criteria

  • Have both lower wisdom teeth (third molars) that are stuck in the jawbone.
  • Be either male or female.
  • Be between 18 and 40 years old.
  • Agree to participate by signing a form called an informed consent.
  • Have lower wisdom teeth that are in a similar position and angle.
  • Be in good general health, classified as **ASA I**, which means no significant health issues.
  • Have not taken any anti-inflammatory medicine for at least 30 days before the surgery.

Who cannot join the trial?

4 criteria

  • Individuals who are not undergoing a third molar extraction cannot participate. A third molar is commonly known as a wisdom tooth.
  • Participants must be within the specified age range for the study.
  • Both males and females are eligible, but certain groups may be excluded based on specific criteria.
  • Individuals considered part of a vulnerable population are not eligible. A vulnerable population includes people who may have limited ability to make informed decisions, such as children or those with certain disabilities.
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Investigated drugs

Dexamethasone is a medication used in this trial to reduce swelling, pain, and difficulty in opening the mouth after surgery. The study is comparing two ways of giving this medication: one is by taking it orally, and the other is by injecting it into the masseter muscle, which is a muscle in the jaw. The goal is to see which method is more effective when given right before surgery to remove impacted lower wisdom teeth.

What is already known about the treatment

Dexamethasone – Dexamethasone is administered either orally or through an intramuscular injection into the masseter muscle. It is currently being studied for its effectiveness in reducing swelling, limited mouth opening, and pain associated with the extraction of lower third molars, commonly known as wisdom teeth. The medication is a well-established corticosteroid used to decrease inflammation and suppress the immune response. At the molecular level, dexamethasone works by binding to glucocorticoid receptors, which leads to the inhibition of pro-inflammatory cytokines and other mediators of inflammation. It is classified pharmacologically as a corticosteroid.

Investigated diseases

Third Molar Extraction – This is a common dental procedure involving the removal of the third molars, also known as wisdom teeth. These teeth are the last to develop and usually emerge in late adolescence or early adulthood. Often, there is not enough space in the mouth for these teeth to grow properly, leading to impaction or misalignment. This can cause pain, swelling, and infection, necessitating their removal. The procedure typically involves making an incision in the gum to access and extract the tooth. Recovery may include swelling and discomfort, which gradually improves over a few days.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517000-11-00Protocol codeCOR-24Estimated enrolment3 patientsSponsorComplutense University Of Madrid

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