Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint as Treatment for TMJ Anterior Disc Displacement Without Reduction
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Patients' subjective pain experience (numerical rating scale)
研究概览
简要总结
To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw exercise together with stabilizing splints for treatment of TMJ anterior disc displacement without reduction
详细描述
To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw exercise together with stabilizing splints for treatment of TMJ anterior disc displacement without reduction
PICO:
Population (P): Patients with symptomatic anterior disc displacement without reduction.
Intervention (I): pivot splint.
Comparator (C): stabilizing repositioning splint (ARS).
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
- 15 Years 至 50 Years（Child, Adult）
- 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
- •Individuals with systemic diseases that can affect TMJ
- •History of TMJ surgery
- •Individuals with osteoarthritis
- •Individuals under TMD management
- •Individuals wearing full or partial dentures
- •Reducing dislocations of the articular disc
- •Consequences of condyle fractures and/or fracture of another maxillofacial zone
- •In therapy for the same pathologies
- •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
研究组 & 干预措施
stabilizing splint
Active Comparator: 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 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. intervention: pivot splint
干预措施: pivot splint (Device)
stabilizing splint
Active Comparator: 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 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. intervention: pivot splint
干预措施: stabilizing splint (Device)
pivot splint
Experimental: pivot 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.
Other Names: PS
干预措施: pivot splint (Device)
pivot splint
Experimental: pivot 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.
Other Names: PS
干预措施: stabilizing splint (Device)
结局指标
主要结局
Patients' subjective pain experience (numerical rating scale)
时间窗: 6 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
- Protrusion (distance in mm)(6 months)
- Maximum mouth opening (Unit: mm)(6 months)
- Lateral excursion (Unit: mm)(6 months)
研究者
Hesham Mohamed mohamed elsayed safa
Resident at National Cancer Institute
Cairo University