Therapeutic Effect of Microfragmented Adipose Tissue (Lipogems) Injection on Maximum Interincisal Opening Versus Injectable Platelet-rich Plasma (PRP) for the Treatment of Anterior Disc Displacement With Reduction : A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- maximum interincisal opening
研究概览
简要总结
this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.
The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function compared with arthrocentesis and injection of platelets rich plasma (prp)in patients with TMJ internal derangement and osteoarthritis.
Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.
Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.
For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function, compare this technique with prp injection.
详细描述
Anterior disc displacement with reduction (DDwR) of the temporomandibular joint (TMJ) is a prevalent condition characterized by the displacement of the articular disc during jaw movement, often leading to pain, clicking sounds, and restricted mouth opening. Traditional treatments include conservative approaches such as physical therapy, occlusal splints, and pharmacological interventions. However, for patients unresponsive to these methods, intra-articular injections of regenerative therapies like microfragmented adipose tissue (MFAT) and platelet-rich plasma (PRP) have emerged as promising alternatives.
Arthrocentesis first described by Nitzan et al. [1.2] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.
Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.
In addition to arthrocentesis:
Microfragmented Adipose Tissue (MFAT) Injections MFAT involves the extraction and processing of adipose tissue to create a suspension rich in mesenchymal stem cells, growth factors, and extracellular matrix components. This suspension is then injected into the affected joint to promote tissue repair and reduce inflammation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should have one or more signs and symptoms of these
- •Disc displacement assessed by clinical examination and MRI
- •Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
- •Mouth Opening: Limited range of motion or difficulty with full mouth opening .
- •Clicking: Audible clicking.
- •Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
排除标准
- •Previously diagnosed hematological and neurological conditions;
- •Previous malignant head and neck neoplasms;
- •Contraindication to fat harvesting.
- •Uncooperative patients.
- •connective tissue disorders.
- •a pacemaker or any other metal prosthesis in the body.
研究组 & 干预措施
microfragmented adipose tissue
干预措施: microfragmented adipose tissue (Other)
platelet-rich plasma
干预措施: platelet-rich plasma (Other)
结局指标
主要结局
maximum interincisal opening
时间窗: 1 week , 3 months
maximum interincisal opening and it is measured by caliper in mm
次要结局
- presence or absence of joint clicking (binary outcome)(1 week , 3 months)
- change in pain severity(1 week , 3 months)