Etoricoxib for Postoperative pain after mandibular third molar extraction

Inclusion criteria

• {"criterion_text":"- 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"}

Exclusion criteria

• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Based on literature data, it is anticipated that the patients in the etoricoxib group will experience a greater reduction in postoperative pain and discomfort compared to the control (placebo) group. This outcome is hypothesized based on the pharmacological properties of the drug.","definition_or_measurement_approach":""}

Methods

• Patients 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 and who present during regular clinic hours (Hungary)

Hungary

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

22-01-2025

Processing Time Days

6

Number Of Sites

1

Number Of Participants

75

Primary sponsor

Full Name

Semmelweis University

Organisation Type

Educational Institution

Country Of Registered Address

Hungary