Clinical trial NCT06130176: Single-step Functional Sinus Endoscopy and Transoral Surgery
Official title: Single-step Functional Sinus Endoscopy and Transoral Surgery Enhance Odontogenic Sinusitis Treatment Outcomes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maxillary Sinusitis
Keywords: Maxillary Sinusitis
Odontogenic Maxillary Sinusitis
Lead sponsor: Qassim University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
name: Tanta University
First posted: 2023-11-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The OMS will be treated with Single-step Functional Sinus Endoscopy and Transoral Surgery via department-integrated therapy
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Thickness of the sinus mucosa
timeFrame: Two weeks after intervention
measure: Thickness of the sinus mucosa
timeFrame: One month after intervention
measure: Thickness of the sinus mucosa
timeFrame: Three monthsafter intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Buraydah
country: Saudi Arabia
facility: Ghada Amin Khalifa
state: Qassim Province
Study officials:
affiliation: College of Dentistry, Qassim University, Saudi Arabia
name: Ghada A Khalifa, professor
role: PRINCIPAL_INVESTIGATOR
References: