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临床试验/NCT06530745
NCT06530745已完成4 期

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

Hospital of the Ministry of Interior, Kielce, Poland1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2024年7月18日最近更新:
适应症

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

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

研究者

发起方
Hospital of the Ministry of Interior, Kielce, Poland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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