Clinical Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism- Related Orofacial Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in Orofacial Pain Score in Bruxism Patients (n=30) as Measured by the Visual Analog Scale (VAS) in retaliation to adverse effect of each drug used.
研究概览
简要总结
To evaluate the clinical effectiveness of chlorzoxazone in comparison to orphenadrine Citrate in relieving the orofacial pain in bruxers. Subjects and Methods: 60 patients above 15-years old complaining of orofacial and temporomandibular disorder/pain, with no history of chronic systemic illness, will be recruited. Patients will randomly be allocated into two groups (n=30): the first group will receive Relaxon (chlorzoxazone) twice daily for two weeks, while the second group will receive Norgesic (orphenadrine Citrate) twice daily for two weeks as well. Pain severity will be assessed by Visual Analogue Scale (VAS) at day 0, 7, and day 14. In addition, a temporomandibular joint (TMJ) evaluation form will be utilized to assess the TMJ parameters before and after initiation of the treatment protocol, i.e at 0 and 14 days. Non parametric statistical analysis will be conducted to explain the results using SPSS V29.
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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged above 15 years-old complaining of orofacial and temporomandibular disorder/pain.
- •Patients with no history of chronic systemic illness.
排除标准
- •Patients with orofacial injuries.
- •Patients with head injuries.
- •Patients Taking analgesics for the last 14 days.
研究组 & 干预措施
Chlorzoxazone Group
Using Chlorzoxazone
干预措施: Chlorzoxazone (Drug)
Orphenadrine Citrate group
干预措施: Orphenadrine Citrate (Drug)
结局指标
主要结局
Change From Baseline in Orofacial Pain Score in Bruxism Patients (n=30) as Measured by the Visual Analog Scale (VAS) in retaliation to adverse effect of each drug used.
时间窗: From enrollment to the end of treatment at 2 weeks
次要结局
未报告次要终点
研究者
Noor R. Al-Hasani
Asst. Prof. Dr.
University of Baghdad