Single-step Functional Sinus Endoscopy and Transoral Surgery

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.

Conditions

• Maxillary Sinusitis

Interventions

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.

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.

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.

Sponsors & Collaborators

• Beni-Suef University

  collaborator OTHER

• Tanta University

  collaborator OTHER

• Qassim University

  lead OTHER

Principal Investigators

• Ghada A Khalifa, professor · College of Dentistry, Qassim University, Saudi Arabia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-11

Primary Completion

2025-12-01

Completion

2026-07-01

Countries

• Saudi Arabia

Study Locations