Effect of Low-Level Laser Therapy Versus CAD/CAM Michigan Splint on Patients With Temporomandibular Muscle Disorders Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Electromyographic muscle activity
研究概览
简要总结
This study aimed to evaluate the sustainability of the efficacy of using low level laser therapy and CAD/CAM Michigan splint in improving the range of mandibular movements, muscle activity and reducing the pain.
详细描述
56 female patients were randomly divided into two groups, Group A: Patients received applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions. Group B: Patients received hard occlusal splints (Michigan splints) of 2 mm thickness constructed on their upper teeth, the hard occlusal splint was 3D digitally printed. ARCUS digma facebow was used to evaluate the range of mandibular movements affected from TMJ problems. The opening measurements of the patient were taken using a millimeter ruler. Electromyogram (EMG) was used to evaluate muscle activity. Visual analogue scale (VAS) was used to evaluate the pain intensity. All was done before the beginning of the treatment at three and six months follow up period.
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 (Outcomes Assessor)
盲法说明
Blocked randomization technique was used to divide the patients into two equal groups using sealed envelopes, the person who was in charge for randomization was blinded to the group allocation of the patients. The outcome assessor also didn't know the allocated groups, and the patients were instructed not to mention their groups to the assessors.
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •tenderness in the TMJ or muscles of mastication (e.g., temporalis and masseter) that might get worse in the morning or with eating, headache, periauricular pain, teeth wear that appears in the form of multiple smooth shinny facets, teeth mobility, and malocclusion
排除标准
- •pregnant females, breast feeders, patients having pacemakers, heart disease, tumors, general connective tissue disease e.g., Rheumatoid arthritis, psychiatric disorders, skeletal morphology as class II or III, TMJ clicking sounds, local skin infection over the masseter or temporalis, symptoms that may be referred to other disorders of orofacial region (tooth ache, trigeminal neuralgia, migraine), or patients using medications such as Muscle relaxant, Steroids, Dopamine precursors like L dopa and Aminoglycoside
- •Vulnerable groups (prisoners, mental disorders, patients not capable of decision making).
结局指标
主要结局
Electromyographic muscle activity
时间窗: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
The change in muscle activity was assessed using EMG in terms of Microvolt
Range of mandibular movement
时间窗: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
The increase in the range of movement measured using ARCUS digma in terms of angular inclination.
次要结局
- Mouth opening(Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months))
- Pain intensity(Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months))