Single-step Functional Sinus Endoscopy and Transoral Surgery

NCT06130176 | Recruiting

• 1 other identifier: # REC-FDBSU/02062022-03/EM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Sinusitis

Keywords

Maxillary Sinusitis; Odontogenic Maxillary Sinusitis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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.

Procedure: Single-step Functional Sinus Endoscopy and Transoral Surgery

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.

Procedure: Functional sinus endoscopy

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

Procedure: Trans oral Surgery

Interventions

Single-step Functional Sinus Endoscopy and Transoral Surgery 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.

Also known as: FSE/OS

Single-step Functional Sinus Endoscopy and Transoral Surgery

Functional sinus endoscopy 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.

Also known as: FSE

Functional sinus endoscopy

Trans oral Surgery 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.

Also known as: OS

Trans oral Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Qassim University: lead
• Beni-Suef University: collaborator
• Tanta University: collaborator

Study Sites (1)

Ghada Amin Khalifa

Buraidah, Qassim Province, 1162, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Maxillary Sinusitis

Condition Hierarchy (Ancestors)

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ghada A Khalifa, professor

  College of Dentistry, Qassim University, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada A Khalifa, Professor

CONTACT

00966504840248; g.khalifa@qu.edu.sa

Samir A Elborolosy, Lecturer

CONTACT

00201275872173; dr.samir.elborolose@dent.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Maxillofacial Surgery and Diagnostic Science

Model Details: The OMS will be treated with Single-step Functional Sinus Endoscopy and Transoral Surgery via department-integrated therapy

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 14, 2023
• Study Start: November 11, 2018
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting six months after publication
• Access Criteria: IPD will be shared up on request by sending to the corresponding author

Locations

SA (1)