Study on Pain Relief After Wisdom Tooth Surgery Using Etoricoxib and Celecoxib for Patients Undergoing Mandibular M3 Removal

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What is this study about?

This clinical trial is focused on studying the effects of two painkillers, etoricoxib and celecoxib, in managing pain after the removal of wisdom teeth, specifically the lower third molars. The removal of these teeth, often referred to as mandibular third molars, can lead to significant discomfort during the recovery period. The purpose of the study is to compare how well these medications can reduce pain following this type of dental surgery.

Participants in the study will be randomly assigned to receive either etoricoxib, celecoxib, or a placebo. The study is designed to be double-masked, meaning neither the participants nor the researchers will know which treatment each participant is receiving, to ensure unbiased results. The trial will observe the effects of these medications over a short period, focusing on their ability to lessen pain and discomfort after the surgery.

The study aims to determine if one of these medications is more effective than the other in reducing postoperative pain. It is anticipated that those receiving etoricoxib may experience a greater reduction in pain compared to those receiving a placebo, based on the known properties of the drug. This research could help improve pain management strategies for patients undergoing wisdom tooth removal in the future.

1 joining the study

Upon joining the study, participants are randomly assigned to one of two groups. Each group receives a different medication to evaluate its effect on pain reduction after the removal of a mandibular third molar (M3M).

2 medication administration

Participants in the first group receive etoricoxib, while those in the second group receive celecoxib. Both medications are taken orally.

The specific dosage and frequency of administration are determined by the study protocol and are designed to assess the preventive painkiller effect of each medication.

3 surgery and postoperative period

Participants undergo the surgical removal of mandibular third molars, classified according to the Pell & Gregory system. The surgery is performed at the Department of Oral and Maxillofacial Surgery and Dentistry.

The postoperative period involves monitoring the pain levels and any discomfort experienced by participants. This is crucial for evaluating the effectiveness of the medications.

4 evaluation of pain reduction

The primary goal is to assess the reduction in postoperative pain and discomfort. It is anticipated that participants receiving etoricoxib may experience greater pain relief compared to those in the control group.

The evaluation is based on the pharmacological properties of the medications and is conducted over a specified period following the surgery.

5 completion of the study

The study is estimated to conclude by January 1, 2027. Participants’ data will contribute to understanding the effectiveness of the medications in reducing postoperative pain after M3M surgery.

Who Can Join the Study?

Patients must be between the ages of 18 and 30 years old.
Both male and female patients can participate.
Patients should not have any history of systemic diseases. This means they should not have diseases that affect the entire body, like diabetes or heart disease.
Patients must be outpatients, meaning they visit the clinic for treatment but do not stay overnight.
Patients need a valid referral to participate in the study.
Patients must belong to the area served by the Department of Oral and Maxillofacial Surgery and Dentistry of Semmelweis University.
Patients should visit during regular clinic hours.
The study involves the removal of mandibular third molars, which are the lower wisdom teeth.
The wisdom teeth should be classified as Class I or Class II and Position A or B, according to the Pell & Gregory classification system. This system helps to describe the position and difficulty of removing wisdom teeth.
Teeth classified as Class II, Position B are not included because they are more difficult to remove and may take longer to heal.
The classification of the wisdom teeth will be done using a special imaging system called AGFA IMPAX.

Who Cannot Join the Study?

Patients who have not had their lower wisdom teeth (also known as mandibular M3) removed cannot participate.
Patients who are not in the recovery period after having their lower wisdom teeth removed cannot participate.
Patients who are under 18 years old cannot participate.
Patients who are part of a vulnerable population, meaning they need special protection or care, cannot participate.

Where you can join this trial?

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Site Name	City	Country	Status
Semmelweis University	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Hungary	Not yet recruiting	01.09.2022

Trial locations

Investigated drugs:

Etoricoxib is a medication used to relieve pain and inflammation. In this clinical trial, it is being tested for its effectiveness in reducing pain after M3M surgery, which is a type of dental surgery. The goal is to see how well it can prevent pain compared to another painkiller.

Celecoxib is another pain-relieving medication being studied in this trial. Like etoricoxib, it is used to manage pain and inflammation. The trial aims to compare its ability to reduce pain after M3M surgery with that of etoricoxib, to determine which is more effective for pain prevention in this context.

Investigated diseases:

Procedural pain

Postoperative Period After Mandibular M3 Removal – This condition refers to the phase following the surgical extraction of the third molar, commonly known as the wisdom tooth, from the lower jaw. During this period, patients often experience pain, swelling, and discomfort as the body begins to heal from the surgical procedure. The intensity of these symptoms can vary depending on factors such as the complexity of the extraction and the individual’s pain threshold. The healing process involves the formation of a blood clot in the socket, which is crucial for proper recovery. Over time, the swelling and pain typically decrease as the tissues repair and the area stabilizes. Proper care and management during this period are essential to ensure a smooth recovery and to minimize complications.

Trial ID:

2025-520695-26-00

Protocol code:

COX2M3M

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pain Relief After Wisdom Tooth Surgery Using Etoricoxib and Celecoxib for Patients Undergoing Mandibular M3 Removal

What is this study about?

Who Can Join the Study?

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