Effect of Genetic Polymorphisms on Response to Preoperative NSAIDs in Endodontic Postoperative Pain Management

Официальное название

The Effect of Genetic Polymorphisms on the Response to Preoperative Non-Steroidal Anti-Inflammatory Drugs in the Management of Endodontic Postoperative Pain

Обзор

This study aims to evaluate the influence of genetic polymorphisms on the effectiveness of preoperative non-steroidal anti-inflammatory drugs (NSAIDs) in managing postoperative pain following endodontic treatment. Participants will receive standard preoperative NSAIDs before undergoing root canal therapy, and their pain responses will be assessed. Genetic analysis will be performed to investigate possible associations between drug response and individual gene variations. The study seeks to improve personalized approaches in endodontic pain management.

Вмешательства

• Препарат Ibuprofen 600 mg
  A single oral dose of 600 mg ibuprofen will be administered prior to the endodontic procedure to evaluate its preemptive analgesic effect on postoperative dental pain.
• Препарат diclofenac sodium
  A single oral dose of 100 mg diclofenac sodium will be administered to participants in the Diclofenac Sodium Group prior to the endodontic procedure. This intervention is designed to assess the preemptive analgesic efficacy of diclofenac sodium in the control of postoperative dental pain.
• Препарат Placebo
  A single oral dose of a placebo tablet, identical in appearance to the active drugs, will be administered to participants in the Placebo Group prior to the endodontic procedure. This group serves as the control to evaluate the true analgesic efficacy of the active interventions.

Первичные конечные точки

• Postoperative pain intensity [Срок оценки: 7 days after treatment]

Критерии участия

Критерии включения

• Patients aged between 18 and 65 years
• Vital mandibular molar teeth diagnosed with symptomatic apical periodontitis
• ASA physical status classification I or II
• Preoperative VAS pain score greater than 50
• No known genetic disorders (e.g., Down syndrome, congenital insensitivity to pain)

Критерии исключения

• Patients classified as ASA III or higher
• Pregnant women or those suspected of being pregnant
• Presence of root canal curvature greater than 25° (Schilder classification)
• Patients with generalized periodontitis
• Presence of periodontal pockets deeper than 3 mm in the affected tooth
• History of systemic disease or known allergies
• Patients with diagnosed psychiatric or psychological disorders
• Presence of swelling, sinus tract, or preoperative tenderness on palpation
• Patients with bruxism
• Presence of resorption in the affected tooth
• Use of analgesic or anti-inflammatory drugs within 12 hours prior to the procedure
• Teeth with root fractures, ankylosis, or pathological mobility

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ataturk University, Faculty of Dentistry, Department of Endodontics — Erzurum

Публикации

• AlRahabi MK. Predictors, prevention, and management of postoperative pain associated with nonsurgical root canal treatment: A systematic review. J Taibah Univ Med Sci. 2017 May 9;12(5):376-384. doi: 10.1016/j.jtumed.2017.03.004. eCollection 2017 Oct. PMID 31435267

Идентификаторы

NCT: NCT06937853 · B.30.2.ATA.0.01.00/297

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗