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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 study about?

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.

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 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 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 surgical procedure

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

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Site Name City Country Status
Clbnthzqrtp Uytdeemusc Oh Mzqgvt Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
03.02.2025

Trial locations

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.

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 ID:
2024-517000-11-00
Protocol code:
COR-24
Trial Phase:
Therapeutic confirmatory (Phase III)

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