Efficacy of Etoricoxib and Celecoxib in Postoperative Pain Management Following Mandibular Third Molar Extraction: A Randomized, Double-Masked Trial

Trial ID: 2025-520695-26-00
Protocol: COX2M3M
Sponsor: Semmelweis University

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Diseases & Conditions

Procedural pain Postoperative analgesia

Objectives

The primary objective of this clinical trial is to evaluate the **pain reduction** effect of two different painkillers, **etoricoxib** and **celecoxib**, following the surgical removal of the mandibular third molar (M3M). This study aims to determine which medication provides superior analgesic efficacy during the **postoperative period** after M3M surgery. Understanding the comparative effectiveness of these medications is clinically relevant as it can guide postoperative pain management strategies, potentially improving patient outcomes and comfort.

Participants

The clinical trial involves a total of 75 **participants**, both male and female, aged between 18 and 30 years. The study population is composed of individuals in the **postoperative period after mandibular M3 removal**. Participants are selected from outpatients with valid referrals who belong to the catchment area of the Department of Oral and Maxillofacial Surgery and Dentistry of Semmelweis University. These individuals present during regular clinic hours and have no history of systemic diseases. The trial excludes vulnerable populations and focuses on the removal of mandibular third molars classified as Class I or Class II and Position A or B, according to the Pell & Gregory classification system. However, third molars classified as Class II, Position B are excluded due to increased surgical difficulty and prolonged wound healing. The sponsor did not provide information on the total number of subjects involved in the study.

Plans and Procedures

The clinical trial is designed to evaluate the **pain** reduction effects of two painkillers, **etoricoxib** and **celecoxib**, following mandibular third molar (M3) surgery. This study is a randomized, double-masked, controlled trial, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thereby minimizing bias. The trial is authorized to take place in Hungary and is expected to conclude by January 1, 2027. The recruitment of participants began on September 1, 2022, and the study aims to enroll 75 male and female patients aged between 18 and 30 years, who have no history of systemic diseases.

Participants will undergo a screening visit to confirm eligibility based on specific criteria, including the classification of their third molars using the Pell & Gregory classification system. The study involves the removal of mandibular third molars classified as Class I or Class II and Position A or B, with exceptions for more challenging cases. Following the screening, participants will be randomly assigned to receive either etoricoxib or celecoxib, administered orally. The maximum daily dose for etoricoxib is 60 mg, while for celecoxib, it is 200 mg, with a treatment period of one day.

Study visits will include follow-up assessments to monitor pain levels and any adverse effects. The primary endpoint is the reduction in postoperative pain and discomfort, with the hypothesis that the etoricoxib group will experience greater pain relief compared to the control group. The expected length of participant involvement is short, given the one-day treatment period. However, participants may be withdrawn from the study if they experience significant adverse effects or if they do not adhere to the study protocol. The trial is categorized as a phase IV clinical trial, indicating it is a low-intervention study focused on post-marketing surveillance of the drugs involved.

Treatment

The clinical trial involves the administration of **ETORICOXIB**, a chemical compound classified under the ATC code M01AH05. The pharmaceutical form of ETORICOXIB is denoted as PHF00082MIG. The medication is administered orally, with a maximum daily dose of 60 mg. The treatment period is limited to one day. ETORICOXIB is not formulated for pediatric use and is not classified as an orphan drug. Participant compliance with the dosing regimen will be monitored throughout the trial.

In addition to ETORICOXIB, the trial also includes the administration of **CELECOXIB**, another chemical compound, classified under the ATC code M01AH01. CELECOXIB is provided in the pharmaceutical form PHF00005MIG and is also administered orally. The maximum daily dose for CELECOXIB is 200 mg, with a treatment period of one day. Similar to ETORICOXIB, CELECOXIB is not a pediatric formulation and is not designated as an orphan drug. Compliance with the dosing schedule will be closely monitored to ensure adherence to the trial protocol.

Both ETORICOXIB and CELECOXIB are used as painkillers in this study, with the primary objective being the evaluation of their pain reduction efficacy following M3M surgery. The trial is designed as a randomized, double-masked clinical trial to ensure unbiased results. No additional non-experimental treatments, such as standard-of-care therapy or placebo, are specified in the trial protocol. The trial is authorized and conducted in accordance with regulatory standards.

Efficacy

The efficacy of the clinical trial comparing the preventive painkiller effects of **etoricoxib** and **celecoxib** after mandibular third molar (M3M) surgery will be assessed primarily through the reduction of postoperative pain and discomfort. This primary endpoint is based on literature data suggesting that patients in the etoricoxib group are expected to experience a greater reduction in these symptoms compared to the control group, which is hypothesized due to the pharmacological properties of the drug. The trial is designed as a randomized, double-masked study to ensure objective evaluation of the outcomes.

Inclusion and Exclusion Criteria

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Inclusion Criteria

At the Department of Oral and Maxillofacial Surgery and Dentistry of Semmelweis University, we will enroll 75 male and female patients aged between 18 and 30 years, who have no history of systemic diseases. Patients participating in the study will be selected from outpatients with valid referrals who belong to the catchment area of the Department of Oral and Maxillofacial Surgery and Dentistry of Semmelweis University (based on the National Public Health and Medical Officer Service [ANTSZ] allocation) and who present during regular clinic hours. The study will involve the removal of mandibular third molars classified as Class I or Class II and Position A or B, according to the Pell & Gregory classification system. An exception will be made for third molars classified as Class II, Position B, as these cases involve more challenging anatomical conditions, which may lead to increased surgical difficulty and prolonged wound healing. The classification of third molars will be performed using the AGFA IMPAX imaging

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Exclusion Criteria

In the planned clinical trial, all patients with any of the following hypersensitivities, conditions, or diseases, whether occurring independently or in combination with other conditions, will be excluded: hypersensitivity to sulfonamides, lactose monohydrate, sodium lauryl sulfate, povidone K 30, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, shellac, propylene glycol, iron oxide, calcium hydrogen phosphate, microcrystalline cellulose, carnauba wax, hypromellose, or triacetin. Patients who have previously experienced asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria, or other allergic-type reactions following the use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 (cyclooxygenase-2) inhibitors, will also be excluded. Pregnancy or breastfeeding, congestive heart failure, ischemic heart disease, clinically manifested forms of peripheral arterial disease and/or cerebrovascular disease, hypertension, liver failure, impaired renal function, active peptic ulcers, gastrointestinal bleeding, and inflammatory bowel disease are exclusion criteria. Due to potential drug interactions with the selective COX-2 inhibitors under investigation, patients currently on medication or who have been on long-term medication will be excluded. Additionally, patients who have taken any type of pain relief medication within one week prior to the planned wisdom tooth extraction will also be excluded. Only non-smoking patients will participate in the trial due to slower wound healing and increased postoperative complications. Similarly, pregnancy, breastfeeding, and hypersensitivity to COX inhibitors are considered exclusion criteria. Due to potential drug interactions with the selective COX-2 inhibitors under investigation, patients currently on medication or who have been on long-term medication will be excluded. Additionally, patients who have taken any type of pain relief medication within one week prior to the planned wisdom tooth extraction will also be excluded. Only non-smoking patients will participate in the trial due to slower wound healing and increased postoperative complications. Similarly, pregnancy, breastfeeding, and hypersensitivity to COX inhibitors are considered exclusion criteria.