Single-step Functional Sinus Endoscopy and Transoral Surgery

Not Applicable

Recruiting

• Conditions: Maxillary Sinusitis
• Interventions: Procedure: Single-step Functional Sinus Endoscopy and Transoral Surgery; Procedure: Functional sinus endoscopy; Procedure: Trans oral Surgery

• Registration Number: NCT06130176
• Lead Sponsor: Qassim University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-11-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-11
• Study First Posted: 2023-11-14
• Status Verified: 2024-08
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-12-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. A diagnosis of OMS that is not responding to dental treatment and/or medical treatment
2. 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)
3. Availability of clinical, radiographic, and ESS data.

Exclusion Criteria

1. Maxillary sinus malignancy
2. Sinuses with a previous surgery
3. Non-odontogenic Sinusitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-step Functional Sinus Endoscopy and Transoral Surgery	Single-step Functional Sinus Endoscopy and Transoral Surgery	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.
Functional sinus endoscopy	Functional sinus endoscopy	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.
Trans oral Surgery	Trans oral Surgery	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

Primary Outcome Measures

Name	Time	Method
Thickness of the sinus mucosa	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

Trial Locations

Locations (1)

Ghada Amin Khalifa; 🇸🇦 Buraydah, Qassim Province, Saudi Arabia