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临床试验/NCT06937151
NCT06937151已完成不适用

Arthrocentesis Versus Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction

Cairo University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Thera Bite RANGE OF MOTION scale

研究概览

简要总结

The present study will be designed to compare the short- and medium-term results of arthrocentesis and non-surgical methods Rocabado approach in early disc displacement without reduction.

详细描述

This study will be designed to provide a comparison between the effect of the Rocabado approach as a conservative treatment and temporomandibular joint arthrocentesis in temporomandibular joint disc displacement without reduction.

Delimitations:

This study will be delimited in the following aspects:

  1. Patients:

The study group will be composed of sixty-eight patients with temporomandibular joint disc displacement without reduction will be enrolled in the study. Group A: It will be composed of thirty-four patients with TMJ disc displacement without reduction who are started on the Rocabado approach- 4 - 6×6 exercise program. Include therapeutic exercise, and patient education focusing on the temporomandibular joint. Repeat measurements will be performed on 1st measurement at the baseline before any intervention, 2nd measurement after 8 weeks of treatment by a physiotherapist. Group B: It will be composed of thirty-four patients with disc displacement without reduction who are started on TMJ arthrocentesis procedure with medical and nursing care. 2. Equipment and tools:

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
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •History of a sudden reduction in the mandibular opening. Unassisted mandibular opening 35 mm.
  • •Mandibular opening with assistance increased by ≥3 mm from
  • •unassisted opening, with a prior history of click, click disappearance, and a sudden decrease in opening.
  • •Magnetic resonance imaging (MRI) diagnosis of Disc displacement without reduction.
  • •Persistence of the symptoms indicated in the first item for a Maximum of 3 weeks.
  • •clinical diagnosis of unilateral Disc displacement without reduction of the temporomandibular joint.

排除标准

  • •History of major jaw trauma.
  • •Dentofacial deformity.
  • •Psychiatric illness.
  • •Chronic headache. Presence of other disorders involving the TMJ.

研究组 & 干预措施

Group A (Study group) ROCABADO APPROACH :

Active Comparator

Group A (Study group):

This group includes thirty-four patients with temporomandibular joint disc displacement without reduction, who will receive the Rocabado approach exercise program 6×6 AND MANIPULATION

干预措施: Rocabado approach exercise program 6×6 and manibulation . (Procedure)

Group B (Control group) ARTHOROCENTESIS:

Active Comparator

This group includes thirty-four patients with temporomandibular joint disc displacement without reduction who will receive TMJ Arthrocentesis

干预措施: Arthrocentesis (Procedure)

结局指标

主要结局

Thera Bite RANGE OF MOTION scale

时间窗: pre treatment and eight weeks post treatment

Will be used for measuring the Maximal interincisal opening, lateral movement will be measured. Measuring Maximal Interincisal Opening : 1. Patient Positioning: The patient opens their mouth as wide as possible without discomfort. 2. Scale Placement: The range of motion scale is positioned so that the notch rests on the edge of the lower incisor. 3. Measurement: Rotate the scale until it contacts the upper incisor, and record the reading at the point of contact. Measuring Lateral Excursion Movement: 1. Scale Alignment: Rest the range of motion scale against the lower incisors with the upper and lower teeth closed together. 2. Arrow Alignment: Align the arrow on the scale with an interproximal space between two upper teeth. 3. Measurement: Move the mandible laterally (side-to-side) and record the measurements on the lateral side.

8-Items Jaw Functional Limitation Scale

时间窗: pre treatment and eight weeks post treatment

Disability related to orofacial pain, which makes it a generic tool that one can use it for different types of orofacial pain conditions. 1. Preparation: Select a quiet and distraction-free environment. 2. Understanding the Scale: Rate each item on a scale from 0 (no limitation) to 10 (severe limitation). 3. Completing the Questionnaire: Carefully read each question and reflect on your jaw function over the past week. 4. Items to Rate: Assess difficulties in chewing, mouth opening, and emotional expression. 5. Time Required: Completion typically takes less than 5 minutes. 6. Post-Completion: Higher scores indicate greater functional limitations.

Visual analog scale

时间窗: pre treatment and eight weeks post treatment

One of the pain rating scales, 1. Preparation: Ensure the VISUAL ANALOG SCALE line is accurately printed to scale (10 cm) with endpoints labeled: * 0 = No pain. * 10 = Worst imaginable pain. 2. Patient Instructions: Ask the patient to mark their current pain level on the line. 3. Score Measurement and Interpretation: Measure the distance in centimeters from the "no pain" end (0) to the patient's mark to determine the score out of 10. Higher scores indicate greater pain intensity (e.g., a mark at 6 cm corresponds to a pain level of 6/10). 4. Recall Period: Patients report either their current pain or pain experienced within the last 24 hours, depending on assessment context.

次要结局

未报告次要终点

研究者

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

Eman Shawkey Mohamed

Physical Therapist

Cairo University

研究点 (1)

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