跳至主要内容
临床试验/NCT05620758
NCT05620758招募中不适用

Clinical Effectiveness of a Laser Therapy in Patients With Temporomandibular Disorders (A Randomized Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月30日最近更新:
适应症
干预措施

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

Experimental

干预措施: Nd YAG laser (Other)

Diode laser 980 nm

Experimental

干预措施: diode laser (980 nm) (Other)

Diode laser 940 nm

Experimental

干预措施: diode laser (940 nm) (Other)

Diode laser 660 nm

Experimental

干预措施: diode laser (660 nm) (Other)

Diode laser 635 nm

Experimental

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

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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