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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06130176
Enrollment
36
Registered
2023-11-14
Start date
2018-11-11
Completion date
2027-07-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinusitis

Keywords

Maxillary Sinusitis, Odontogenic Maxillary Sinusitis

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.

Interventions

PROCEDURESingle-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.

PROCEDUREFunctional 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.

PROCEDURETrans 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

Qassim University
Lead SponsorOTHER
Beni-Suef University
CollaboratorOTHER
Tanta University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Thickness of the sinus mucosaTwo weeks after interventionOn 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

Countries

Saudi Arabia

Contacts

CONTACTGhada A Khalifa, Professor
g.khalifa@qu.edu.sa00966504840248
CONTACTSamir A Elborolosy, Lecturer
dr.samir.elborolose@dent.bsu.edu.eg00201275872173
PRINCIPAL_INVESTIGATORGhada A Khalifa, professor

College of Dentistry, Qassim University, Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026