A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults, Randomized, Double- Blind, Parallel-Group, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)
研究概览
简要总结
Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Removal of 2 to 4 impacted third molars
排除标准
- •Pregnancy or breastfeeding
- •Ibuprofen contraindications.
- •Allergy to any of the intervention components.
研究组 & 干预措施
Intervention Group ibuprofen 400 and Curcumin
干预措施: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg (Dietary Supplement)
Intervention Group ibuprofen 200 and Curcumin
干预措施: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg (Dietary Supplement)
Intervention Group ibuprofen 400 and placebo
干预措施: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure (Other)
结局指标
主要结局
Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)
时间窗: 8 hours
次要结局
- Time to pain half pain gone (in minutes)(8 hours)
- Duration of pain half gone (in minutes)(8 hours)
- Any adverse events (facial swelling, nausea, vomiting, headache) (%)(8 hours)
- Total pain relief (TOTPAR) %(8 hours)
