Single-step Functional Sinus Endoscopy and Transoral Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Maxillary Sinusitis
• Intervention / Treatment: Procedure: Single-step Functional Sinus Endoscopy and Transoral Surgery; Procedure: Functional sinus endoscopy; Procedure: Trans oral Surgery

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghada A Khalifa, Professor; Phone Number: 00966504840248; Email: g.khalifa@qu.edu.sa
• Study Contact Backup: Name: Samir A Elborolosy, Lecturer; Phone Number: 00201275872173; Email: dr.samir.elborolose@dent.bsu.edu.eg

Study Locations

• Saudi Arabia
  • Qassim Province
    • Buraydah, Qassim Province, Saudi Arabia, 1162
      • Recruiting
      • Ghada Amin Khalifa
      • Contact: Samir A Elborolosy, Lecturer; Phone Number: 00201275872173; Email: dr.samir.elbrolose@dent.bsu.edu.eg
      • Contact: Mohamed M Elshamaa, Lecturer; Phone Number: 00201001503601; Email: drmelshamaa@dent.bsu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Single-step Functional Sinus Endoscopy and Transoral Surgery; In each patient, the operation will be carried out by an otorhinolaryngologist and a maxillofacial surgeon. The procedures of the functional sinus endoscopy (FSE) will performed as follow: Under general anesthesia, the origin of the turbinate, and the lateral nasal wall will be conducted. The following stage will be infundibulotomy, which ensures that the uncinate process will be completely removed. The ostium will be dilated with a Stammberger dilatator starting with a 0-degree endoscope then shift to a 30- or 45-degree endoscope to clean the sinus. The cavity will be irrigated after removal of the odontogenic diseases and the purulent discharge will suctioned.In addition to FSE, the maxillofacial surgeon will conduct the necessary oral surgery procedures.The needed transoral procedures will be tooth extraction, oro-antral fistula closure or cystectomy.; Other Names: FSE/OS
Active Comparator: 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.	Procedure: Functional sinus endoscopy; All patients in this group will only be treated with FSE, which will be conducted by an otolaryngologist. The FSE procedures will be carried out in the same way as the group of Single-step Functional Sinus Endoscopy and Transoral Surgery.; Other Names: FSE
Active Comparator: 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	Procedure: Trans oral Surgery; Every patient in this group will only be treated with transoral surgical procedures to remove dental pathology. Oral and maxillofacial surgeons will undertake these treatments. The procedure will be either tooth extraction, oro-antral fistula closure, or cystectomy. If extraction is not needed, endodontic treatment will be performed to remove necrotic pulp. The oro-antral fistula will be closed in two layers using a buccal advanced flap and a palatal rotational flap. In the case of odontogenic cysts, the lesion will be removed by raising a trapezoidal flap.; Other Names: OS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of the sinus mucosa	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	Two weeks after intervention
Thickness of the sinus mucosa	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	One month after intervention
Thickness of the sinus mucosa	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	Three monthsafter intervention

Collaborators and Investigators

• Sponsor: Qassim University
• Collaborators: Beni-Suef University; Tanta University
• Investigators: Principal Investigator: Ghada A Khalifa, Professor, College of Dentistry, Qassim University, Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2018
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 11, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Maxillary Sinusitis; Odontogenic Maxillary Sinusitis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Sinusitis; Maxillary Sinusitis
• Other Study ID Numbers: # REC-FDBSU/02062022-03/EM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: Starting six months after publication
• IPD Sharing Access Criteria: IPD will be shared up on request by sending to the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No