Efficacy of Intra-Articular Magnesium Sulfate Compared With Hyaluronic Acid and Saline Following Temporomandibular Joint Arthrocentesis: A Three-Arm Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 4
研究概览
简要总结
Temporomandibular joint (TMJ) arthrocentesis is a well-established minimally invasive treatment for patients with TMJ arthralgia and internal derangement. Although intra-articular hyaluronic acid is frequently administered following arthrocentesis to improve pain relief and joint function, evidence regarding the efficacy of intra-articular magnesium sulfate remains limited. Magnesium sulfate has demonstrated analgesic and anti-inflammatory properties through N-methyl-D-aspartate (NMDA) receptor antagonism and modulation of calcium influx; however, its clinical use in TMJ disorders has not been adequately investigated.
This investigator-initiated, single-center, three-arm randomized controlled pilot trial was conducted to compare the clinical effectiveness and safety of intra-articular magnesium sulfate, hyaluronic acid, and normal saline administered after TMJ arthrocentesis in patients diagnosed with TMJ arthralgia according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
The primary outcome was the change in chewing pain measured using the Visual Analog Scale (VAS) at 4 weeks. Secondary outcomes included maximum mouth opening, Jaw Functional Limitation Scale-8 (JFLS-8), Oral Health Impact Profile-14 (OHIP-14), Graded Chronic Pain Scale version 2.0 (GCPS v2.0), Patient Health Questionnaire-4 (PHQ-4), analgesic consumption, and adverse events.
详细描述
Temporomandibular disorders (TMDs) are among the most common causes of chronic orofacial pain and functional limitation. Arthrocentesis is considered an effective minimally invasive treatment for patients with persistent TMJ arthralgia who do not respond adequately to conservative therapy. In addition to mechanical lavage of inflammatory mediators, several intra-articular agents have been investigated to enhance postoperative recovery and improve clinical outcomes. Hyaluronic acid is widely used because of its viscoelastic, lubricating, and anti-inflammatory properties.
Magnesium sulfate has attracted increasing interest because of its analgesic effects mediated primarily through NMDA receptor antagonism, modulation of calcium influx, and reduction of peripheral sensitization. Although beneficial effects have been reported in several musculoskeletal and postoperative pain conditions, evidence regarding intra-articular magnesium sulfate administration in temporomandibular joint disorders remains scarce.
This investigator-initiated, single-center, randomized controlled pilot trial was designed to compare intra-articular magnesium sulfate with hyaluronic acid and normal saline following TMJ arthrocentesis. Adult patients diagnosed with TMJ arthralgia according to DC/TMD criteria were randomly allocated to one of three parallel treatment groups. Arthrocentesis was performed using a standardized single-needle upper joint compartment technique, followed by administration of the allocated intra-articular agent.
The primary endpoint was the change in chewing pain measured by the Visual Analog Scale (VAS) at 4 weeks. Secondary endpoints included maximum mouth opening, Jaw Functional Limitation Scale-8 (JFLS-8), Oral Health Impact Profile-14 (OHIP-14), Graded Chronic Pain Scale version 2.0 (GCPS v2.0), Patient Health Questionnaire-4 (PHQ-4), analgesic consumption, and treatment-related adverse events. The study was designed to evaluate the clinical effectiveness and safety of magnesium sulfate as a potential adjunctive intra-articular treatment following TMJ arthrocentesis.
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
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •Age between 18 and 65 years. Diagnosis of temporomandibular joint arthralgia and/or painful disc displacement with reduction or disc displacement without reduction with limited opening according to DC/TMD Axis I criteria.
- •Predominantly unilateral temporomandibular joint symptoms lasting for at least 6 weeks.
- •Resting or chewing-related pain intensity of at least 4 on a 0-10 Visual Analog Scale.
- •Clinical indication for temporomandibular joint arthrocentesis. Ability to understand and complete the Turkish-language questionnaires. Provision of written informed consent. -
排除标准
- •Active local or systemic infection. Advanced degenerative temporomandibular joint disease, defined by clinical crepitus together with advanced imaging findings or Wilkes stage IV-V disease.
- •Intra-articular injection within the previous 3 months. Temporomandibular joint arthroscopy or open joint surgery within the previous 6 months.
- •Pregnancy or breastfeeding. Coagulopathy or use of anticoagulant medication that could not be discontinued. Known hypersensitivity to any of the study agents. Severe psychiatric disorder or any condition preventing completion of the study questionnaires.
结局指标
主要结局
Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 4
时间窗: Baseline and Week 4 (±5 days)
Temporomandibular joint pain during chewing was assessed using an 11-point Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Change was calculated by comparing the Week 4 score with the baseline score. A greater reduction indicates greater improvement.
次要结局
- Change From Baseline in Resting Temporomandibular Joint Pain Intensity(Baseline, Week 1 (Day 7 ±2 days), Week 4 (±5 days), and Week 12 (±10 days))
- Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 1 and Week 12(Baseline, Week 1 (Day 7 ±2 days), and Week 12 (±10 days))
- Change From Baseline in Jaw Functional Limitation Scale-8 Score(Baseline, Week 1, Week 4, and Week 12)
- Change From Baseline in Oral Health Impact Profile-14 Score(Baseline, Week 4, and Week 12)
- Change From Baseline in Maximum Mouth Opening(Baseline, Week 1, Week 4, and Week 12)
- Change in Graded Chronic Pain Scale Version 2.0 Classification(Baseline and Week 12)
- Change From Baseline in Patient Health Questionnaire-4 Score(Baseline and Week 12)
研究者
ceren dayanan
Assistant Professor Ceren Dayanan
Yuzuncu Yil University