Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT06916234
Brief Summary:
Acute dental pain is one of the most challenging conditions to treat and manage in dental practice. The aim of this study was to compare the efficacy of naproxen sodium + codeine phosphate (550/30 mg) and dexketoprofen trometamol + paracetamol (25/300 mg) in the treatment of acute dental pain in individuals with acute pericoronitis caused by impacted wisdom teeth.
Detailed Description:
This randomised, prospective, single-blind study was conducted on patients who presented to Van Yuzuncu Yil University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery between January 2023 and December 2023 with the complaint of acute pericoronitis originating from the lower impacted third molar teeth. At the first visit, the patients underwent a clinical examination to evaluated the patients' complaints, whether the complaints were caused by impacted lower third molar , and the presence of infection. For radiographic assessment, panoramic radiographs were taken of the region of the impacted lower third molars about which the patients complained. Patients who met the inclusion criteria were randomised into two groups, by the research assistants using the Research Randomizer (version 4.0) program to ensure blinding of the surgeons. Group A (active control group) received 550 mg naproxen sodium + 30 mg codeine phosphate and group B (research group) received 25 mg dexketoprofen trometamol + 300 mg paracetamol 2 times daily for 7 days; and amoxicillin 500 mg 3 times daily for 5 days in addition to analgesics for infection control due to acute pericoronitis. Paracetamol 500 mg was administered as rescue medication. Patients were instructed not to take rescue medication unless they had to and, if they did, to record the time and number of doses on the form given to them. Patients in the study groups received the first dose of the drugs from us and continued to receive subsequent doses every 12 hours.
A Visual Analogue Scale (VAS) with numbers ranging from 0 - no pain to 10 - un-bearable pain was used to evaluate pain. Patients were asked to record their VAS score on the form at the 6th hour (T1), 12th hour (T2), 18th hour (T3), 24th hour (T4), 2nd day (T5), 3rd day (T6), 4th day (T7), 5th day (T8), 6th day (T9) and 7th day (T10) after the first dose (T0 of study drug. Obtained data was analyzed and evaluated statistically.
Study:
NCT06916234
Study Brief:
Protocol Section:
NCT06916234