跳至主要内容
临床试验/NCT06256042
NCT06256042已完成不适用

Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of Disc Displacements of the Temporomandibular Joint

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Jaw function available in mouth opening and moviments of jaw

研究概览

简要总结

The goal of this clinical trial is to compare occlusal splint and arthrocentesis in patients with disc displacement with/without reduction. The main question it aims to answer are:

• Is there a more effective treatment for this cases?

Participants will answer a questionary about pain and functional limitations.

Researchers will compare Group 1(occlusal plate) and Gruoup 2 (arthrocentesis) to see if there is pain reduction and functional improvement in patients with disc displacement with/without reduction

详细描述

Introduction

Temporomandibular joint disc displacement is a disorder in which the articular disc is anteriorly displaced from its correct position in relation to the mandibular condyle and mandibular fossa. Traditionally, the initial treatment of disc displacements involves several conservative measures, among them, the stabilizing interocclusal splint. However, in cases where there is associated opening limitation, such as intermittent lock and closed-lock, arthrocentesis has been suggested as another initial treatment modality due to its faster effect in preventing disease progression to a more advanced stage, in addition to reducing the chances of pain chronicity and central sensitization. Objectives: The present study aimed to compare and analyze the effectiveness and benefits of performing arthrocentesis as the initial treatment in patients with DDWR with intermittent lock and in patients with DDWoR, compared to the stabilizing interocclusal splint. Additionally, it had as secondary objectives to characterize the sample according to demographic, systemic, local and psychosocial factors in both groups and to correlate the clinical characteristics of the included patients with the imaging findings of the MRI scans. Methods: A randomized, prospective, longitudinal pilot study was performed. The sample was obtained by convenience from a demand through consultations and referral, among patients treated at the Oral and Maxillofacial Surgery Service of HCFMUSP, from June 2021 to July 2023. Patients with diagnoses of: DDWR intermittent lock and DDWoR with opening mouth limitation. Study patients underwent an initial assessment using a clinical questionnaire (DC/TMD) and underwent an initial TMJ MRI. Then, they were randomly divided into two groups according to the treatment to which they would be submitted: stabilizing inter-occlusal splint (group 1) or arthrocentesis (group 2). After treatment was instituted, patients were evaluated at 1, 2, 3 and 6 months regarding clinical parameters of pain, functionality and psychosocial status.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at least 18 years old;
  • Diagnosed with disc displacement with reduction with intermittent block or disc displacement without reduction;
  • Availability of clinical follow-up for 6 months.

排除标准

  • Pregnant patients;
  • Patients undergoing conservative or invasive interventions to treat TMD in the last 6 months;
  • Inability to use a stabilizing occlusal splint;
  • Presence of toothache, neoplasms or medical contraindication for study participation.

结局指标

主要结局

Jaw function available in mouth opening and moviments of jaw

时间窗: 6 months

millimeter scale

次要结局

  • Pain available through of Visual Analogue Scale(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gustavo Grothe Machado

Director of Oral and Maxillofacial Surgery Service

University of Sao Paulo General Hospital

研究点 (2)

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