A Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Temporomandibular Joint.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Change in Pain Severity Measured by Numerical Rating Scale (NRS)
研究概览
简要总结
The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with
concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with
anterior disc displacement with reduction of TMJ who did not respond favorably to conservative
treatment and to compare and infer which among the two procedures is more satisfactory,
whether dextrose 5% injection or Arthrocentesis.
详细描述
The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with
concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with
anterior disc displacement with reduction of TMJ who did not respond favorably to conservative
treatment and to compare and infer which among the two procedures is more satisfactory,
whether dextrose 5% injection or Arthrocentesis.
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 (Care Provider)
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
- •Inclusion Criteria
- •Patients diagnosed with anterior disc displacement with reduction of TMJ with pain,limited mouth opening and
- •painful clicking who underwent conservative therapy with physiotherapy but failed to receive any relief after 3
- •months of conservative therapy.
- •Age ranges from 18 to 50 years.
- •Patients with adequate follow up duration for outcome assessment.
排除标准
- •Patients having pain or reduced mouth opening due to fracture of the condyle.
- •patients having any degenerative changes in the TMJ.
- •patients having other systemic diseases such as polyarthritis.
- •patients having any neurological disorders.
- •Pregnant and lactating women.
研究组 & 干预措施
Group 1 patients with anterior disc displacement with reduction
干预措施: dextrose 5% (Other)
Group 2 patients with anterior disc displacement of reduction
干预措施: Arthrocentesis/Saline (Other)
结局指标
主要结局
Change in Pain Severity Measured by Numerical Rating Scale (NRS)
时间窗: Measured at baseline, 3 days and 3 months after injection
Primary Outcome Measure: 1. Change in Pain Severity Measured by Numerical Rating Scale (NRS) Pain severity will be assessed using the Numerical Rating Scale (NRS) (0-10), where 0 = no pain and 10 = severe pain. Participants will report their pain levels at each time point. The mean change in NRS scores from baseline will be calculated and analyzed . Data Aggregation: Mean change in NRS score
次要结局
- Change in Maximal Interincisal Opening (MIO) Measured in Millimeters(Measured at baseline, 3 days and 3 months after injection)
研究者
Sandy maged habib ibrahim
sandy Maged Habib Ibrahim
Cairo University