Evaluation of the Effects of Different Analgesics on Pain and Health-related Quality of Life of Patients With Pericoronitis in the Short-term Period: A Randomized, Double-blind, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oral Health-Related Quality of Life Scores Evaluated
研究概览
简要总结
Pericoronitis is a painful inflammatory condition which is well known for its negative impact on quality of life of those affected. The aim of this study was to test two hypotheses: (1) that topical application of Benzydamine is as effective as oral Diclofenac or Flurbiprofen in improving pain and quality of life of patients with pericoronitis and (2) that there would be no difference between the effects of the two oral NSAIDs on pain and quality of life of patients with pericoronitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young adults aged 18 years or over
- •Diagnosed with mild pericoronitis
- •Having semi-impacted mandibular third molar
- •Symptoms of pain and localized swelling
排除标准
- •History of allergy to diclofenac, flurbiprofen, benzydamine or other NSAIDs
- •Use of systemic antibiotics or analgesics within 3 days before admission
- •The patients who had symptoms of severe pericoronitis such as fever higher than 101°F, dysphagia, trismus or facial swelling.
研究组 & 干预措施
Diclofenac
Diclofenac group, which received diclofenac 50 mg capsules (Cataflam) and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor.
干预措施: Diclofenac (Drug)
Flurbiprofen
Flurbiprofen group, which received flurbiprofen 100 mg capsules and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor.
干预措施: Flurbiprofen (Drug)
Benzydamine
Benzydamine group, which received benzydamine 0.045 g, 30 mL oral sprays (Tantum Verde) and placebo capsules. Placebo capsules contained starch.
干预措施: Benzydamine (Drug)
结局指标
主要结局
Oral Health-Related Quality of Life Scores Evaluated
时间窗: one week after drug prescribed
For the post - treatment period, the Oral Health-Related Quality of Life scores change was evaluated with the help of the 5-point Likert-type scale where each item was scored from 1 (no trouble) to 5 (lots of trouble). Evaluated periods were 1, 2, 3, 5 and 7 days
次要结局
- Pain Scores Evaluated(one week after drug prescribed)
研究者
abdullah alalwani
Research Assistant
Near East University, Turkey