Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06130176

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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)

Post-operative Follow-up

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

Loading map...

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

Similar Trials

A Placebo Controlled Randomised Study of Balloon Sinuplasty ...

Maxillary Sinusitis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here