Clinical Effectiveness of a Laser Therapy in Patients With Temporomandibular Disorders (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Pain
研究概览
简要总结
TMD involves a set of multiple clinical manifestations where the pain is prevalent. Treatment ideally should be noninvasive and innocuous such as photobiomodulation
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
- 20 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain at TMJ area.
- •Pain at masseter and temporalis muscles.
- •Age ranges between 20 and 40 years old.
- •Presence of full or nearly full complement of natural teeth
排除标准
- •Patients who have radiographic evidence of degenerative conditions of TMJ.
- •Patients under current dental or physical therapy that could affect TMD.
- •History of recent trauma.
- •The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
- •Pregnant and lactating females
研究组 & 干预措施
Nd YAG laser
干预措施: Nd YAG laser (Other)
Diode laser 980 nm
干预措施: diode laser (980 nm) (Other)
Diode laser 940 nm
干预措施: diode laser (940 nm) (Other)
Diode laser 660 nm
干预措施: diode laser (660 nm) (Other)
Diode laser 635 nm
干预措施: diode laser (635 nm) (Other)
结局指标
主要结局
Change in Pain
时间窗: Baseline and 1 month
Visual analogue scale of pain (VAS),using a 0-10-point scale 0 score means no pain" and score 10 means "worst pain
Chaneg in pressure pain threshold
时间窗: Baseline and 1 month
The pressure pain threshold measurements for the trapezius, infraspinatus, and extensor carpi radialis muscles were performed at the center of the upper trapezius, at a position 2-3 fingers below the center of the spine of scapula, and at a position 3-4 fingers below the lateral epicondyle of the humerus, respectively. The pressure pain threshold of the extensor indicis proprius was measured by pressing toward the medial side of the radius from a position 3 fingers above the radial styloid process. The investigator placed the digital pressure algometer on a site to be inspected and pressed against the tester in a vertical direction while increasing the force at a constant rate of 1 kg/cm2. The investigator instructed the subjects to express pain either by saying "ouch" or raising their hands when only slight pain was felt. After all 8 muscles were investigated, the subjects were allowed to rest for 5 min. This procedure was repeated a total of 3 times.
Change in Oral-health Related Quality of life (OHRQoL)
时间窗: Baseline and 1 month
The OHIP-14 has 14 questions related to the evaluation of OHRQoL. The responses were recorded in a 5-point Likert scale ranging from never to very often (score is 0 to 4). Then, we calculated the total scores of all domains, and a higher score indicated poor OHRQoL. The highest possible total score of all the OHIP-14 domains is 56
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University
