Correlation Between MRI Findings and Clinical Improvement Following TMJ Injection With Hyaluronic Acid and Platelet-Rich Plasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Correlation between baseline MRI findings and clinical improvement
研究概览
简要总结
Temporomandibular joint (TMJ) disorders can cause jaw pain, clicking sounds, and difficulty opening the mouth, affecting daily activities such as eating and speaking. This study aims to determine whether magnetic resonance imaging (MRI) findings can help predict how much patients improve after a single injection into the TMJ containing hyaluronic acid and platelet-rich plasma (PRP).
Adults with TMJ internal derangement who have not improved with conservative treatment will receive one injection of hyaluronic acid combined with PRP prepared from their own blood. Participants will be evaluated before treatment and at follow-up visits over 6 months. Assessments will include pain, jaw function, mouth opening, and MRI scans before and after treatment.
The results of this study may improve understanding of the relationship between MRI findings and treatment outcomes and help healthcare providers identify patients who are most likely to benefit from this minimally invasive therapy.
详细描述
Temporomandibular joint (TMJ) internal derangement is one of the most common temporomandibular disorders and is characterized by an abnormal relationship between the articular disc and the mandibular condyle, resulting in pain, joint sounds, and limitation of mandibular movement. Although clinical examination remains the primary diagnostic approach, magnetic resonance imaging (MRI) is considered the gold standard for evaluating TMJ soft tissue structures, including disc position, joint effusion, retrodiscal tissue, and inflammatory changes. However, MRI findings do not always correlate with symptom severity or treatment outcomes, making their prognostic value uncertain.
Intra-articular injection therapy has become a widely accepted minimally invasive treatment for TMJ internal derangement. Hyaluronic acid (HA) improves joint lubrication, reduces inflammation, and provides chondroprotective effects, whereas platelet-rich plasma (PRP) contains autologous growth factors that may enhance tissue repair and regeneration. The combination of HA and PRP may provide both symptomatic relief and biologic enhancement of joint healing.
This randomized controlled clinical trial aims to evaluate the relationship between MRI findings and clinical improvement following a single intra-articular injection of HA combined with PRP in patients with TMJ internal derangement with reduction. Sixty adult patients aged 18-45 years who have persistent symptoms despite conservative treatment and MRI-confirmed internal derangement with reduction will be enrolled.
Before treatment, all participants will undergo a comprehensive clinical examination, including assessment of pain intensity using the Visual Analog Scale (VAS), joint clicking, and maximum interincisal opening (MIO), as well as MRI evaluation of the affected TMJ. Platelet-rich plasma will be prepared from the participant's own blood and mixed with hyaluronic acid for intra-articular injection into the affected joint.
Clinical evaluations will be performed at baseline and at 1 week, 1 month, 3 months, and 6 months after treatment. MRI examinations will be repeated at 6 months. The primary objective is to determine whether baseline MRI findings correlate with and predict clinical improvement after treatment. Secondary objectives include evaluating changes in pain intensity, maximum mouth opening, and joint clicking following HA and PRP injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients age between (18 -45).
- •Early/intermediate stage according to (Wilkes classification).
- •Patients have painful joint, clicking sound, with or without limited mouth opening.
- •4. Patients unresponsive to conservative treatment.
- •Patient's ability and desire to complete the treatment protocol and follow up visits.
- •6. Patients with internal derangement with reduction confirmed by MRI imaging
排除标准
- •Patient with an inflammatory or connective tissue disease
- •Patient with previous invasive TMJ surgical procedure.
- •neurologic disorders
- •History of injection of any substance into the target TMJ during previous 6 months.
- •5. Patient with history of bony or fibrous adhesion.
- •Internal derangement without reduction.
- •Patient with psychological problem
研究组 & 干预措施
Experimental: Hyaluronic Acid + Platelet-Rich Plasma Injection
Participants with MRI-confirmed temporomandibular joint (TMJ) internal derangement with reduction who have failed conservative treatment will receive a single intra-articular injection consisting of 1 mL hyaluronic acid combined with 1 mL autologous platelet-rich plasma (PRP). Participants will be followed for 6 months with clinical assessments and MRI evaluation.
干预措施: intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich Plasma (Procedure)
结局指标
主要结局
Correlation between baseline MRI findings and clinical improvement
时间窗: Baseline to 6 months
To determine whether baseline magnetic resonance imaging (MRI) findings correlate with and predict clinical improvement following a single intra-articular injection of hyaluronic acid combined with platelet-rich plasma. Clinical improvement will be assessed using pain intensity (Visual Analog Scale), maximum interincisal opening (MIO), and joint clicking. MRI will be repeated at 6 months to evaluate imaging changes.
次要结局
未报告次要终点