Ultrasound-guided vs Conventional Intraarticular Injection of Hyaluronic Acid for Management of Temporomandibular Joint Internal Derangement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain (Visual Analogue Scale)
研究概览
简要总结
The aim of the study will be to evaluate the clinical efficacy of using ultrasound guidance during intra-articular injection of hyaluronic acid in the management of patients with TMJ internal derangement.
详细描述
The temporomandibular joint (TMJ) represents one of the most biomechanically sophisticated and functionally critical articulations in the human body, serving as the primary interface between the mandible and the cranium.
This synovial joint facilitates essential orofacial functions including mastication, phonation, deglutition, and emotional expression through its unique ginglymoarthrodial (hinge-gliding) motion.
Temporomandibular disorders (TMDs) constitute a major public health burden, with epidemiological studies reporting prevalence rates ranging from 5% to 12% in global populations, though subclinical manifestations may affect up to 40% of adults.
The socioeconomic impact is substantial, with chronic TMD patients demonstrating significantly reduced quality-of-life indices comparable to conditions like rheumatoid arthritis, primarily due to persistent pain, functional limitations, and comorbidities with tension-type headaches and sleep disturbances.
Historically, TMJ research evolved from purely mechanical models to contemporary biopsychosocial paradigms that acknowledge multifactorial etiology.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that will be diagnosed disc displacement confirmed clinically and by Magnetic Resonance Imaging (MRI).
- •Patient not responding to conservative therapy
- •Patients age must be (18 - 50).
- •Patients having painful joint, clicking sound, with or without limited mouth opening.
- •Patient's ability and desire to complete the treatment protocol and follow-up visits.
排除标准
- •Patient with an inflammatory or connective tissue disease
- •Patient with previous invasive TMJ surgical procedure.
- •Patient with Neurologic disorders
- •History of injection of any substance into the target TMJ during previous 6 months.
- •Patient with a history of bony adhesion.
- •Malignant disease in the head and neck region.
- •Patient with a psychological problem.
- •Patients having gross mechanical restrictions and condylar fracture
研究组 & 干预措施
Ultrasound guided itra-articular injection of hyaluronic acid
干预措施: Ultrasound guided injection with hyaluronic acid (Device)
Conventional intra-articular injection of hyaluronic acid
干预措施: Conventional (Other)
结局指标
主要结局
Pain (Visual Analogue Scale)
时间窗: preoperative and postoerative after 1 week, 3 month and 6 month
Pain intensity will be assessed by visual analog scale (VAS) score. Zero score for no pain and 10 score for worst pain experienced
Clicking sound
时间窗: preoperative and postoerative after 1 week, 3 month and 6 month
Clicking sound will be assessed as to its presence = 1 or absence = 0.
Range of lateral mandibular excursions
时间窗: preoperative and postoerative after 1 week, 3 month and 6 month
will be masseured by Vernier caliper as the horizontal distance in millimeter from maxillary mid line to mandibular mid line with the patient first moving the mandible to one side than to the other at the maximum extend
Maximum inter-incisal opening (MIO)
时间窗: preoperative and postoerative after 1 week, 3 month and 6 month
will be measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.
次要结局
未报告次要终点
研究者
Muhannad
B.D.S( Aljouf University, 2021. Sakaka, KSA) Master Dgree at Oral surgery department (2022) Affiliation: Mansoura University
Mansoura University