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临床试验/NCT06867744
NCT06867744已完成不适用

Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction: Novel Technique''

Mohamed Moawed Ibrahim Ghoneim, PhD1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2022年1月1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
发起方
入组人数
65
试验地点
1
主要终点
TMJ Pain

研究概览

简要总结

This study aims to evaluate the efficacy of the ESS technique in correcting TMJ internal derangement, with a focus on functional outcomes and patient satisfaction.

详细描述

Background: Internal derangement (ID) of the temporomandibular joint (TMJ) is a prevalent condition characterized by disc displacement, leading to pain, restricted mandibular mobility, and reduced quality of life. While non-surgical treatments are often the first line of management, surgical intervention becomes necessary in refractory cases. Traditional surgical methods, such as arthrocentesis and disc repositioning, have shown variable success rates, particularly in advanced stages of disc damage. This study introduces the Extracapsular Supradiscal Subperiosteal (ESS) surgical procedure, a novel technique designed to address these limitations. Therefore, current study aims to evaluate the efficacy of the ESS technique in correcting TMJ internal derangement, with a focus on functional outcomes and patient satisfaction.

Patients and Methods: A prospective study was conducted on 50 patients (47 females, 3 males; age range: 11-50 years) with TMJ ID refractory to non-surgical management. The ESS procedure was performed to reposition the displaced disc and stabilize retrodiscal tissues without violating the joint capsule. Preoperative and postoperative assessments included pain levels, maximum mouth opening (MMO), and subjective patient feedback.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with stage 3 or stage 4 internal derangements of TMJ radiological and clinical findings should coincide to set up the diagnosis and predict the treatment plan.

排除标准

  • •Age less than 11 years old
  • •Age more than 50 years are excluded

研究组 & 干预措施

Temporomandibular Joint Internal Derangement Correction

Other

The ESS procedure was performed to reposition the displaced disc and stabilize retrodiscal tissues without violating the joint capsule. Preoperative and postoperative assessments included pain levels, maximum mouth opening (MMO), and subjective patient feedback.

干预措施: Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction (Procedure)

结局指标

主要结局

TMJ Pain

时间窗: 3 months

change of pain on a visual analogue scale (VAS) from 0 to 10 with decreased number means less pain

Clicking

时间窗: 3 months

The clicking during mouth opening scores among study participants, both pre- and postoperative

Interincisal Distance Score

时间窗: pre- and post operative (3 days)

Interincisal Distance Scores from score-0 to score-3 to be identified

Jaw deviation during Mouth Opening

时间窗: 3 days

A 13-score evaluating the jaw deviation during mouth opening from score-0 to score-12

HIT-6

时间窗: 3 days

the Headache impact test (HIT-6) both pre- and postoperatively among study participants

次要结局

未报告次要终点

研究者

发起方
Mohamed Moawed Ibrahim Ghoneim, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Moawed Ibrahim Ghoneim, PhD

Associate professor

Sinai University

研究点 (1)

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