Comparison of the preventive painkiller effect of etoricoxib and celecoxib after M3M surgery: A randomized, double-masked clinical trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Semmelweis University

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Stomatognathic Diseases [C07]

Decision date (initial)

2025-01-22

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-520695-26-00

EudraCT number

2020-001638-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

Clinical trial related to the effect of different painkillers (etoricoxib and celecoxib). Evaluation the pain reduction after M3M surgery.

Conditions and MedDRA coding

postoperative period after mandibular M3 removal

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Semmelweis University

Sponsor organisation

Semmelweis University

Address

Maria Utca 52

City

Budapest

Postcode

1085

Country

Hungary

Scientific contact point

Organisation

Semmelweis University

Contact name

Dr. György Komlós

Public contact point

Organisation

Semmelweis University

Contact name

Dr. György Komlós

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications