Actively Recruiting
Single-step Functional Sinus Endoscopy and Transoral Surgery Enhance Odontogenic Sinusitis Treatment Outcomes: a Randomized Controlled Trial
Led by Qassim University · Updated on 2025-04-13
36
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
Q
Qassim University
Lead Sponsor
B
Beni-Suef University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a specific type of sinus infection called odontogenic maxillary sinusitis (OMS), which arises from dental or dento-alveolar issues affecting the floor of the maxillary sinus. This condition requires different treatment approaches than other sinus infections and the study aims to evaluate the effectiveness of combining functional sinus endoscopy and transoral surgery performed together in one step. The study addresses the uncertainty about which specialists should manage OMS and which surgical methods are best suited for treatment. The study compares three treatment approaches: a combined single-step procedure involving both functional sinus endoscopy performed by an otolaryngologist and transoral surgery by an oral and maxillofacial surgeon during the same visit; functional sinus endoscopy alone by an otolaryngologist; and transoral surgery alone by the oral and maxillofacial surgeon. The combined approach includes detailed surgical steps under general anesthesia, such as infundibulotomy and sinus irrigation, along with dental procedures like tooth extraction, fistula closure, or cyst removal. Participants will undergo clinical, radiographic, and endoscopic evaluations before and after treatment. Researchers will measure the thickness of the sinus mucosa at two weeks, one month, and three months following the intervention to assess treatment outcomes. The study uses a randomized, double-blind design and aims to monitor the effectiveness of each treatment method in managing OMS through integrated departmental care.
CONDITIONS
Brief Title
Single-step Functional Sinus Endoscopy and Transoral Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of odontogenic maxillary sinusitis (OMS) not responding to dental or medical treatment
- Agreement on odontogenic cause between ENT specialist and dentist/maxillofacial surgeon confirmed by CT scans
- Availability of clinical, radiographic, and endoscopic sinus surgery (ESS) data
You will not qualify if you...
- Presence of maxillary sinus malignancy
- History of previous surgery on the sinuses
- Sinusitis not caused by odontogenic origin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants undergo either combined functional sinus endoscopy and transoral surgery, functional sinus endoscopy alone, or transoral surgery alone to treat odontogenic maxillary sinusitis. The procedures are performed under general anesthesia by specialists.
1 treatment visit (in-person)
Duration - Up to 3 months after intervention
Participants are monitored after surgery to assess recovery and treatment outcomes, including evaluation of sinus mucosa thickness.
3 follow-up visits (at 2 weeks, 1 month, and 3 months post-intervention)
Trial Site Locations
Total: 1 location
1
Ghada Amin Khalifa
Buraidah, Qassim Province, Saudi Arabia, 1162
Actively Recruiting
Research Team
G
Ghada A Khalifa, Professor
S
Samir A Elborolosy, Lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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