Single-step Functional Sinus Endoscopy and Transoral Surgery

NCT ID: NCT06130176

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-11
• Study Completion Date: 2026-07-01

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.

Conditions

Maxillary Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Single-step Functional Sinus Endoscopy and Transoral Surgery

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Functional sinus endoscopy

Intervention Type: PROCEDURE

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.

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

Group Type: ACTIVE_COMPARATOR

Trans oral Surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

FSE/OS; FSE; OS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: collaborator

Tanta University

OTHER

Sponsor Role: collaborator

Qassim University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Amin Khalifa, PhD

Professor of Maxillofacial Surgery and Diagnostic Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada A Khalifa, professor

Role: PRINCIPAL_INVESTIGATOR

College of Dentistry, Qassim University, Saudi Arabia

Locations

Ghada Amin Khalifa

Buraidah, Qassim Province, Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Ghada A Khalifa, Professor

Role: CONTACT

g.khalifa@qu.edu.sa

00966504840248

Samir A Elborolosy, Lecturer

Role: CONTACT

dr.samir.elborolose@dent.bsu.edu.eg

00201275872173

Facility Contacts

Samir A Elborolosy, Lecturer

Role: primary

dr.samir.elbrolose@dent.bsu.edu.eg

00201275872173

Mohamed M Elshamaa, Lecturer

Role: backup

drmelshamaa@dent.bsu.edu.eg

00201001503601

Other Identifiers

# REC-FDBSU/02062022-03/EM

Identifier Type: -

Identifier Source: org_study_id