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临床试验/NCT06130176
NCT06130176招募中不适用

Single-step Functional Sinus Endoscopy and Transoral Surgery Enhance Odontogenic Sinusitis Treatment Outcomes: a Randomized Controlled Trial

Qassim University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
2
主要终点
Thickness of the sinus mucosa

研究概览

简要总结

Dento- alveolar or dental structural diseases that affect the floor of the maxillary sinus can cause maxillary sinusitis which is known as odontogenic maxillary sinusitis (OMS). Many treatment protocols have been documented to treat OMS. However, There is no unanimity among clinicians on how and who should treat OMS, whether is it otolaryngologist, oral/maxillofacial surgeons, or dentist. Therefore, this study will be will be enrolled to evaluate the efficacy of the Single-step Functional Sinus endoscopy and trans-oral surgery in the management of maxillary sinusitis raised from Odontogenic origin via Department- integrated therapy.

详细描述

The OMS is a well-known but understudied kind of sinusitis that necessitates a treatment regimen different from non-odontogenic sinusitis. It requires specialized attention because it differs in its pathophysiology, microbiology, diagnosis, and therapy than other forms of non-odontogenic sinusitis. There are several surgical techniques have been published to treat odontogenic maxillary sinusitis, such as transoral, transnasal endoscopic, or combined techniques. Multiple specialists are daily facing patients with maxillary sinusitis either odontogenic or non-odontogenic, including otolaryngologist, maxillofacial/oral, and dental surgeons.

The direct transoral method, which involves making a bone window in the anterolateral maxillary wall, is more familiar to maxillofacial/oral surgeons, whereas the transnasal endoscopic approach is gaining favor, particularly among otolaryngologists. There is no unanimity among clinicians on how and who should treat OMS, whether it is otolaryngologist, maxillofacial, or oral surgeon. This is one of the reasons why the results are frequently challenged as reported by others. Therefore, this study will be will be enrolled to evaluate the efficacy of the Single-step Functional Sinus endoscopy and trans-oral surgery in the management of maxillary sinusitis raised from Odontogenic origin via Department- integrated therapy.

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
Double (Participant, Investigator)

盲法说明

This study will be double blinded randomized control trail. The patients and investigators who will collect the data will not be informed about the study

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of OMS that is not responding to dental treatment and/or medical treatment
  • Agreement on the odontogenic cause between an ENT specialist and a dentist/maxillofacial surgeon (There is bone loss surrounding the tooth's root and a connection between the dental lesion and sinus on CT scans)
  • Availability of clinical, radiographic, and ESS data.

排除标准

  • Maxillary sinus malignancy
  • Sinuses with a previous surgery
  • Non-odontogenic Sinusitis

研究组 & 干预措施

Single-step Functional Sinus Endoscopy and Transoral Surgery

Experimental

The patients who will be included in this study will be treated by functional sinus endoscopy and transoral surgery to remove the dental cause in the same visit to treat odontogenic sinusitis. The functional sinus endoscopy will be performed by the otolaryngologist, while the transoral surgery will be performed by oral and maxillofacial surgeon.

干预措施: Single-step Functional Sinus Endoscopy and Transoral Surgery (Procedure)

Functional sinus endoscopy

Active Comparator

The patients who will be included in this study will be treated by functional sinus endoscopy to treat odontogenic sinusitis, and it will be performed by the otolaryngologist.

干预措施: Functional sinus endoscopy (Procedure)

Trans oral Surgery

Active Comparator

The patients who will be included in this study will be treated by transoral surgery to treat odontogenic sinusitis, and it will be performed by by oral and maxillofacial surgeon

干预措施: Trans oral Surgery (Procedure)

结局指标

主要结局

Thickness of the sinus mucosa

时间窗: Three monthsafter intervention

On coronal and sagittal CT scans, the thickness of the sinus mucosa will be measures by using measuring tool of the CT scan machine. For each of these picture sets, six mucosal thickness measurements will be taken. Then the average of these measurements will be calculated

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

Ghada Amin Khalifa, PhD

Professor of Maxillofacial Surgery and Diagnostic Science

Qassim University

研究点 (2)

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