Quintuple Intra-Articular Hyaluronic Acid (HA) Improves and Platelet-Rich Plasma (PRP) Does Not Affect Mandibular Mobility in Temporomandibular Joint (TMJ) Disorders: A Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Mandibular protrusion
研究概览
简要总结
This clinical trial aims to compare the multidirectional mandibular mobility following the treatment of TMJ disorders with same-protocol intra-articular injections of PRP and HA. It is questioned whether there is direct clinical evidence of the superiority of PRP or HA in the injection treatment of TMJ disorders.
详细描述
This study was designed as a two-arm equal-allocation clinical trial with a non-concurrent active treatment control. The study group consisted of consecutive patients receiving PRP injections into the TMJ cavities. The control group consisted of the same number of patients who received HA according to the same protocol. Controls were recruited consecutively, men and women separately, to maintain a consistent male-to-female ratio. The main condition for recruitment was the diagnosis of TMJ pain by a specialist in orthodontics or dental prosthetics and, on this basis, a referral for injection treatment. TMJ pain was diagnosed under the ICOP 2020 guidelines. The treatment was performed at the Maxillofacial Surgery Clinic in Kielce, Poland. The study group received PRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 (Neuation Technologies Pvt. Ltd, Gujarat, India). The control group received 2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria). In both groups, 0.4 mL of the solution was injected per joint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICOP 2020 diagnosis of TMJ pain;
- •informed consent to participate in the study;
- •the possibility of discontinuing the current treatment of the temporomandibular joints;
- •generally accepted indications for injection therapy.
排除标准
- •active cancer;
- •hematopoietic system disease or bleeding diathesis;
- •temporomandibular joint prosthesis;
- •temporomandibular joint ankylosis;
- •skin disease of the preauricular area of the affected side.
结局指标
主要结局
Mandibular protrusion
时间窗: 0 - 6 months
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Mandibular left movement
时间窗: 0 - 6 months
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Mandibular right movement
时间窗: 0 - 6 months
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Mandibular abduction
时间窗: 0 - 6 months
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
次要结局
未报告次要终点
