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临床试验/NCT05983653
NCT05983653已完成不适用

Evaluation of Arthrocentesis With and Without Platelet Rich Plasma Injection in Patients With Disc Displacement With Reduction.

Cairo University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年8月1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
74
试验地点
2
主要终点
TMJ pain

研究概览

简要总结

This study is aiming To evaluate the treatment effect (anti-inflammatory and healing ) of PRP with arthrocentesis versus arthrocentesis alone on the management of anterior disc displacement with reduction

详细描述

The main aim is to determine whether arthrocentesis with and without PRP will affect the treatment outcome of arthrocentesis , in relation to pain , mouth opening, and disc position . PICO

(P): population : patient with TMD and have clinical signs of disc displacement (I): Intervention: arthrocentesis with normal saline (C): Comparison: two groups 150 ml of normal saline lavage and 150 ml arthrocentesis with PRP (O):Outcome :

Interventions: All patients involved in this study will be divided in to two different groups, one group will receive arthrocentesis with PRP and other group received arthrocentesis only

A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations. A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest and MRI to evaluate disc position

Intra operative procedures for 2 groups:

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
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult participants were chosen to participate in this study according to predefined inclusion criteria Wilkes stage II (chronic pain with good range of motion of anterior disk displacement with reduction and patients with painful joint noises occurring during mouth opening and/or closing including the clinical and MRI findings of anterior disc displacement with reduction that not respond to conservative therapies).Willingness and ability to commit follow-up

排除标准

  • Patients were excluded from the study if they had previous TMJ surgery, a medical history of any systematic disease, and patients participating in other studies.

结局指标

主要结局

TMJ pain

时间窗: first day , after 1 week , after 1 month, 3 month and after 6 months of procedure

pain will be measured by Numerical rating scale from 0-10 (0 the lowest pain , 10 the greatest pain) ,will be measured before intervention , immediately after intervention and on follow up ( 1 week , 1 month , 3 month and 6 month after intervention )

次要结局

  • maximum mouth opening(first day , after 1 week , after 1 month, 3 month and after 6 months of procedure)
  • Disc position on TMJ(before procedure and after 6 months of procedure)

研究者

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

Mohammad Ibraheem Mahmoud Alhoor

Principal Investigator ,master degree candidiate

Cairo University

研究点 (2)

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