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临床试验/NCT06916234
NCT06916234已完成4 期

Evaluation of the Analgesic Efficacy of the Combination of Dexketoprofen + Paracetamol and the Combination of Naproxen Sodium + Codeine in Patients With Acute Dental Pain

ibrahim doğru1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月10日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Pain Evaluation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals aged 18 and over
  • Individuals with systemic status ASA0 and ASA1 according to the American Society of Anaesthesiologists (ASA) classification,
  • Individuals with semi-erupted impacted lower third molar teeth associated with acute pericoronitis,
  • Individuals with a VAS score of 5 and above at the first visit.

排除标准

  • pregnant or lactating women,
  • alcohol and/or drug users,
  • those who did not attend post-operative check-ups,
  • those who were using other than the recommended medication,
  • those who developed adverse drug reactions during the study and discontinued medication,
  • those who were allergic to the study drugs,
  • those who underwent additional dental treatment during the study.

研究组 & 干预措施

Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1)

Active Comparator

干预措施: Dexketoprofen Trometamol + Paracetamol (Drug)

Naproxen Sodium + Codeine Phosphate (550 mg + 30 mg, 2X1)

Active Comparator

干预措施: Naproxen Sodium + Codeine Phosphate (Drug)

结局指标

主要结局

Pain Evaluation

时间窗: 7th day

Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).

次要结局

未报告次要终点

研究者

发起方
ibrahim doğru
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ibrahim doğru

assistant professor

Yuzuncu Yıl University

研究点 (1)

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