Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint in Patients With Temporomandibular Joint Anterior Disc Displacement With Reduction . ( Randomized Controlled Clinical Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Patients' subjective pain experience.
研究概览
简要总结
To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.
详细描述
To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.
PICO:
Population (P): Patients with symptomatic anterior disc displacement with reduction.
Intervention (I): Michigan splint. Comparator (C): Anterior repositioning splint (ARS) .
Outcome(O):
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient from 15 to 50 years old.
- •Report of pain in preauricular region worsened by functional activities, such as chewing and talking.
- •Presence of disc displacement with reduction and joint clicking
- •positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI).
排除标准
- •History of TMJ surgery.
- •Individuals with osteoarthritis.
- •Individuals under TMD management.
- •Individuals wearing full or partial dentures.
- •Individuals with major psychological disorders.
- •Nonreducing dislocations of the articular disc
- •Consequences of condyle fractures and/or fracture of another maxillofacial zone.
- •Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis, psoriasis arthritis).
- •Individuals with a recent history of trauma in the face and/or neck area. Individuals with systemic diseases that can affect TMJ
研究组 & 干预措施
Anterior repositioning splint
A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch .
Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position.
Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop .
Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe.
干预措施: Anterior repositioning splint (Device)
Stabilizing splint
A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch .
Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient should be instructed to close in Centric relation . Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop .
Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. All areas, except labial to the mandibular canines, are flattened to the contact marks. This area will create the eccentric guidance.
干预措施: Stabilizing splint (Device)
结局指标
主要结局
Patients' subjective pain experience.
时间窗: 3 months
Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.
次要结局
- Maximum mouth opening.(3 months)
- Lateral excursion.(3 months)
- Protrusion.(3 months)
研究者
Moataz Nasr
Oral and maxillofacial surgery resident in Sahel Teaching hospital
Cairo University