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临床试验/NCT06936072
NCT06936072已完成不适用

Temporomandibular Joint Eminence Augmentation Using Titanium Ring Inlay: A New Surgical Technique

Sinai University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年4月28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
112
试验地点
1
主要终点
Functional improvement

研究概览

简要总结

To evaluate the efficacy of titanium ring inlay in ESS technique in Temporomandibular joint eminence augmentation

详细描述

Background:Temporomandibular joint (TMJ) disorders affect approximately 5-12% of the population, with eminence augmentation being a challenging surgical intervention. Current techniques using autogenous grafts or alloplastic materials present limitations including donor site morbidity, resorption, and implant failure. This study evaluates a novel titanium ring inlay technique for TMJ eminence augmentation, which may offer improved stability, osseointegration, and functional outcomes.

Patients and Methods: A prospective study was conducted on 100 patients (28 males, 72 females; age range: 25-41 years) with TMJ Temporomandibular joint eminence augmentation. Study was performed after ethical approval from Research Ethics Committee, Faculty of Dentistry, Sinai University OMS 01-04-024; . Titanium ring inlay procedure was performed to Temporomandibular joint eminence augmentation. Preoperative and postoperative assessments included pain levels (VAS pain), maximum mouth opening (MMO), Clicking during mouth opening, Headach presence, tinnitus 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
25 Years 至 41 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed TMJ dysfunction requiring eminence augmentation
  • Failed conservative management (≥3 months)
  • Adequate bone stock for inlay placement
  • Willingness to comply with follow-up protocol

排除标准

  • Systemic conditions contraindicating surgery
  • Active TMJ infection
  • Previous TMJ surgery
  • Pregnancy
  • Neuromuscular disorders-

结局指标

主要结局

Functional improvement

时间窗: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).

Measuring the Maximal interincisal opening (MIO; mm)

次要结局

  • Pain Score(Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).)
  • Headache(Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).)
  • Tinnitus(Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).)

研究者

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

Mohamed Moawed Ibrahim Ghoneim, PhD

Associate professor of Oral and Maxillofacial Surgery

Sinai University

研究点 (1)

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