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临床试验/NCT07479693
NCT07479693已完成不适用

Comparative Evaluation Of Hyaluronic Acid, Injectable Platelet-Rich Fibrin, And Dextrose Prolotherapy As Adjuncts To Temporomandibular Joint Arthrocentesis In Patients With Temporomandibular Joint Disorders

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Change in Pain Intensity (Visual Analog Scale, VAS)

研究概览

简要总结

This study aimed to compare the clinical effectiveness of different intra-articular adjunctive therapies used with temporomandibular joint (TMJ) arthrocentesis in patients with temporomandibular joint disorders. TMJ arthrocentesis is a minimally invasive procedure commonly used to reduce pain and improve mandibular function in patients with internal derangements of the temporomandibular joint. In this study, patients diagnosed with TMJ disorders were treated with arthrocentesis alone or arthrocentesis combined with intra-articular injection of hyaluronic acid, injectable platelet-rich fibrin (i-PRF), or dextrose prolotherapy. Clinical outcomes including pain intensity, mandibular range of motion, and functional improvement were evaluated at different follow-up periods. The aim of this study was to compare the effectiveness of these adjunctive treatments and to determine whether any of these intra-articular approaches provides superior clinical outcomes when used with TMJ arthrocentesis.

详细描述

Temporomandibular joint (TMJ) disorders represent a heterogeneous group of conditions affecting the temporomandibular joint, masticatory muscles, and associated structures. These disorders are among the most common causes of chronic orofacial pain and functional impairment. Patients with temporomandibular joint disorders frequently present with symptoms such as joint pain, limited mouth opening, joint sounds, and impaired mandibular movements, which may significantly affect quality of life. The pathophysiology of TMJ disorders is multifactorial and may involve internal derangements of the joint, inflammatory processes, biomechanical alterations, and degenerative changes within the joint structures.

Conservative treatment approaches, including patient education, pharmacologic therapy, occlusal splints, and physiotherapy, are generally considered the first-line management for temporomandibular joint disorders. However, a subset of patients may not achieve adequate symptom relief with conservative treatment. In such cases, minimally invasive surgical procedures, such as temporomandibular joint arthrocentesis, are frequently recommended. Arthrocentesis is a minimally invasive procedure that involves lavage of the superior joint space to remove inflammatory mediators, release adhesions, reduce intra-articular pressure, and improve joint mobility. This technique has been widely used in the management of internal derangements and other temporomandibular joint pathologies and has demonstrated favorable clinical outcomes in terms of pain reduction and functional improvement.

In recent years, several intra-articular adjunctive therapies have been introduced to enhance the therapeutic effects of TMJ arthrocentesis. Hyaluronic acid is one of the most commonly used agents due to its viscoelastic, lubricating, and anti-inflammatory properties. Intra-articular hyaluronic acid injections may help restore the physiological properties of synovial fluid, improve joint lubrication, and contribute to pain reduction and functional recovery. Injectable platelet-rich fibrin (i-PRF) is an autologous platelet concentrate that contains a high concentration of growth factors and cytokines that may promote tissue healing, angiogenesis, and regenerative processes within the joint structures. Dextrose prolotherapy has also gained interest as a regenerative injection therapy that may stimulate fibroblast activity, enhance connective tissue repair, and potentially improve joint stability and function.

Although these intra-articular treatment modalities have been increasingly used in clinical practice, the available evidence regarding their comparative effectiveness when used in conjunction with TMJ arthrocentesis remains limited. Most previous studies have evaluated these therapies separately, and there is a lack of prospective comparative studies assessing different intra-articular adjuncts within the same clinical study design.

The aim of this study was to compare the clinical outcomes of temporomandibular joint arthrocentesis performed alone and arthrocentesis combined with different intra-articular adjunctive treatments, including hyaluronic acid, injectable platelet-rich fibrin (i-PRF), and dextrose prolotherapy. Patients diagnosed with temporomandibular joint disorders and presenting with joint pain and functional limitation were included in the study according to predefined inclusion and exclusion criteria. Following clinical and radiological evaluation, eligible patients were allocated into four treatment groups: arthrocentesis alone, arthrocentesis combined with hyaluronic acid injection, arthrocentesis combined with injectable platelet-rich fibrin (i-PRF), and arthrocentesis combined with dextrose prolotherapy.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting with temporomandibular joint (TMJ) pain, limited mouth opening, and/or unilateral joint pain
  • Patients diagnosed with internal derangement of the temporomandibular joint classified as DC/TMD
  • Patients who did not respond adequately to conservative treatment modalities
  • Patients who underwent temporomandibular joint magnetic resonance imaging (MRI) evaluation
  • Individuals aged 18-65 years

排除标准

  • Individuals who did not provide informed consent or were unwilling to participate in the study
  • Patients whose primary source of pain was myofascial pain dysfunction or cervical-origin pain
  • Pregnant or breastfeeding patients
  • Patients with a known allergy to any of the injected solutions used in the study
  • Patients with systemic joint diseases such as rheumatoid arthritis
  • Patients with acute infection in the temporomandibular joint region
  • Patients with hematological disorders
  • Patients with a history of previous temporomandibular joint surgery
  • Patients with tumors or malignant neoplasms involving the temporomandibular joint
  • Patients with a history of oral or maxillofacial trauma affecting the temporomandibular joint
  • Patients who were unable to cooperate with clinical examination or follow-up procedures

研究组 & 干预措施

Arthrocentesis Alone

Active Comparator

Participants in this group underwent temporomandibular joint arthrocentesis using the standard two-needle technique. No additional intra-articular agent was administered following the lavage procedure. This group served as the control group for comparison with adjunctive intra-articular treatments.

干预措施: Temporomandibular Joint Arthrocentesis (Procedure)

Arthrocentesis + Hyaluronic Acid

Experimental

Participants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of hyaluronic acid (Orthovisc) after the lavage procedure.

干预措施: Temporomandibular Joint Arthrocentesis (Procedure)

Arthrocentesis + Hyaluronic Acid

Experimental

Participants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of hyaluronic acid (Orthovisc) after the lavage procedure.

干预措施: Hyaluronic Acid (Orthovisc) (Drug)

Arthrocentesis + Injectable Platelet-Rich Fibrin

Experimental

Participants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of injectable platelet-rich fibrin (i-PRF), an autologous platelet concentrate prepared from the patient's venous blood.

干预措施: Temporomandibular Joint Arthrocentesis (Procedure)

Arthrocentesis + Injectable Platelet-Rich Fibrin

Experimental

Participants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of injectable platelet-rich fibrin (i-PRF), an autologous platelet concentrate prepared from the patient's venous blood.

干预措施: Injectable Platelet-Rich Fibrin (i-PRF) (Biological)

Arthrocentesis + Dextrose Prolotherapy

Experimental

Participants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of dextrose solution administered as prolotherapy.

干预措施: Temporomandibular Joint Arthrocentesis (Procedure)

Arthrocentesis + Dextrose Prolotherapy

Experimental

Participants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of dextrose solution administered as prolotherapy.

干预措施: Dextrose prolotherapy (DPT) (Drug)

结局指标

主要结局

Change in Pain Intensity (Visual Analog Scale, VAS)

时间窗: Baseline, 1 week, 1 month, and 3 months

Pain intensity was assessed using a Visual Analog Scale (VAS) to evaluate changes in pain levels after temporomandibular joint arthrocentesis alone or in combination with intra-articular hyaluronic acid, injectable platelet-rich fibrin (i-PRF), or dextrose prolotherapy. The Visual Analog Scale (VAS) is presented as a 0-10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity.

Change in Maximum Mouth Opening

时间窗: Baseline, 1 week, 1 month, and 3 months

Maximum mouth opening (MMO) was measured clinically in millimeters to evaluate improvement in mandibular mobility after temporomandibular joint arthrocentesis alone or in combination with intra-articular hyaluronic acid, injectable platelet-rich fibrin (i-PRF), or dextrose prolotherapy.

次要结局

  • Change in Jaw Functional Limitation Scale Score (JFLS-8)(Baseline, 1 month, and 3 months (The 1-week assessment was not performed because the questionnaire evaluates symptoms over the preceding month; therefore, a 1-week measurement could cause temporal overlap and affect response interpretation.))
  • Change in Graded Chronic Pain Scale Score (GCPS 2.0)(Baseline, 1 month, and 3 months (The 1-week assessment was not performed because the questionnaire evaluates symptoms over the preceding month; therefore, a 1-week measurement could cause temporal overlap and affect response interpretation.))
  • Change in Pain Drawing Score(Baseline, 1 week, 1 month, and 3 months)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emel Bulut

Professor, Department of Oral and Maxillofacial Surgery, Ondokuz Mayis University

Ondokuz Mayıs University

研究点 (1)

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