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临床试验/NCT05883982
NCT05883982已完成2 期

Analysis of the Results of Treatment With Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction.

Hospital of the Ministry of Interior, Kielce, Poland1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
Articular pain

研究概览

简要总结

The aim of the study will be to analyze the results of injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. The treatment will consist in the administration of autologous blood products into the cavities of the temporomandibular joints.

详细描述

The aim of the study is to analyze the results of injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. The analyzed treatment will consist in the administration of autologous blood products into the cavities of the temporomandibular joints. We intend to conduct a prospective study without a control group. Patients suffering from pain in the temporomandibular joints and/or limited jaw mobility, in whom injection treatment is the treatment of choice, and patients in whom first-line therapies (pharmacotherapy, physiotherapy, splint therapy) did not bring the desired results, and intra-articular injections are a generally accepted continuation of the therapeutic protocol. Qualified patients will be treated with autologous blood products (injectable platelet-rich fibrin). Data from specialist literature support the safety and effectiveness of administering the above-mentioned substance to the cavities of the temporomandibular joints. The use of blood products in the form of intra-articular injections is medically justified both in the case of pain in the temporomandibular joints and/or in clinical conditions with limited jaw mobility. Currently available scientific publications on the comparison of the effectiveness of therapy with the use of various autologous substances are not numerous and do not give a clear answer to the question of what therapeutic protocol (type of substance, dose, number of administrations, joint compartment) is the most effective in the given observation period. This study aims to clarify some of these issues in regard to the above-mentioned blood product, and thus to obtain valuable clinical data that may help clinicians in choosing the appropriate use of intra-articular injections in patients with temporomandibular joint dysfunction.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18;
  • 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

  • bleeding diathesis;
  • mental illness;
  • temporomandibular joint prosthesis;
  • temporomandibular joint ankylosis;
  • skin disease of the preauricular area of the affected side.

结局指标

主要结局

Articular pain

时间窗: 0 - 6 months

Temporomandibular joint pain intensity on Visual Analogue Scale (form "0" - no pain to "10" - worst pain)

Mandibular mobility

时间窗: 0 - 6 months

Range of mandibular abduction (between incisal edges, in mm)

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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