Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc.
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
- None
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
- •TMJ with audible and palpable click.
- •Patients with anterior disc displacement as detected by MRI.
- •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 who have anterior disc dislocation without reduction.
- •Previous history of TMD treatment.
- •History of recent trauma.
- •The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
- •Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
- •Pregnant and lactating females.
- •Patients with known allergy to botulinum toxin type A.
- •Patients suffering from neurological disorders.
研究组 & 干预措施
Low level laser therapy
干预措施: Low level laser therapy (Device)
Botulinum toxin type A
干预措施: Botulinum toxin type A (Drug)
Anterior repositioning appliance
干预措施: Anterior repositioning appliance (Device)
结局指标
主要结局
Pain level
时间窗: 3 months
This will be assessed using the visual analogue scale (VAS) with score ranges from 0 (lowest) to 10 (highest). Higher scores indicate greater pain levels.
Temporomandibular joint dysfunction
时间窗: 3 months
Using Helkimo Anamnestic Index that includes 5 items, each having 3 possible answers scored 0, 1 or 5. The 1st item assesses limitations in range of jaw movement \& is divided to 4 sections: maximum mouth opening, protrusion \& lateral shift. For mouth opening , value of \>40mm scores 0, 30-39mm scores 1 \& \<30mm scores 5. Protrusion \& lateral shifts score 0 if the measurement is ≥7mm, 1 if ranging between 4-6mm and 5 if it is \<4mm. These sections are added together to get a total that scores 0 if the sum of the 4 sections is 0, 1 if the subtotal is between 1-4 \& 5 if the subtotal is \>4. The 2nd item evaluates joint alterations that produce deviations, sounds and joint locks. The 3rd item evaluates pain when performing movements. The 4th item evaluates masticatory muscles pain. The 5th item evaluates pain on palpation in the prearticular area of TMJ. The 5 items are added and scored; 0: no TMJ involvement, 1-9: mild involvement, 10-19: moderate involvement \& 20-25: severe involvement
Temporomandibular joint clinical evaluation
时间窗: 3 months
Magnetic Resonance Imaging (MRI) will be performed for all patients using a 3 Tesla MRI scanner with a head coil. Gradient T2 (T2\*) and proton-density (PD) weighted spin echo (SE) sequences will be carried out in closed and open mouth positions in the oblique sagittal plane. MRI is considered the gold standard (objective) in imaging the soft tissue components of the TMJ.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria