Effect of Laser Irradiation Versus Anterior Repositioning Splint in Treatment of Disc Displacement With Reduction A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Level of temporomandibular joint pain: assessed by using subjective visual analogue scale
研究概览
简要总结
comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.
详细描述
to compare the clinical effects of Laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo Laser. Diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and MRI findings was again performed after a 3 months observation 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients having TMD in the form of disc displacement with reduction as verified from signs and symptoms during clinical examination and confirmed from the MRI.
- •Good general health: The patient must be medically free from any systemic disease or health problems.
- •Adult patients 18 years old and above.
- •No previous orthodontic treatment.
- •No previous TMJ treatment or surgery.
排除标准
- •Patients with multiple missing posterior teeth.
- •Muscle pain due to systemic disease.
- •Dental related pain.
- •Congenital abnormality, neoplasia or acute trauma.
- •Previous TMJ treatment or surgery.
- •Any medical condition that prohibits MRI acquisition.
研究组 & 干预措施
Laser therapy
12 laser sessions over 3 months
干预措施: Laser therapy (Device)
anterior re-positioning splint therapy
anterior re-positioning splint worn for 8 hours during night time for 3 months
干预措施: anterior re-positioning splint (Device)
inactive laser therapy
placebo laser for 12 sessions over 3 months
干预措施: inactive Laser therapy (Device)
结局指标
主要结局
Level of temporomandibular joint pain: assessed by using subjective visual analogue scale
时间窗: 3 months
current level of temporomandibular joint pain assessed by using subjective visual analogue scale from 1 to 10 according to the research diagnostic criteria of temporomandibular disorders diagnostic sheets, zero indicates no pain, while 10 indicates the worst pain
次要结局
- click: joint sound(3 months)
- disc recapture(3 months)
- limitation of mandibular movements(3 months)
研究者
Nada Elzawahry
assistant lecturer
Cairo University