Chronic Rhinosinusitis-An Update on Epidemiology, Pathogenesis and Management.
Silviu Albu
https://pubmed.ncbi.nlm.nih.gov/32708447Actively Recruiting
Led by Ohio State University · Updated on 2026-05-26
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are investigating the use of three-dimensional (3D) printing technology to improve nasal irrigation outcomes for adults with chronic rhinosinusitis, with or without nasal polyps. Chronic rhinosinusitis is a common condition causing nasal obstruction, facial pain, nasal discharge, and loss of smell, significantly affecting quality of life. This study aims to personalize nasal irrigation techniques based on individual nasal anatomy to enhance treatment effectiveness and patient satisfaction, especially for those who are not candidates for surgery or prefer less invasive options. Participants use a 3D-printed nasal replica derived from their CT scans to help determine the best head position for nasal irrigation. The study compares three groups: a control group using the standard FDA-recommended head position, a backfill group using a specific 90-degree ear-to-shoulder tilt, and a model group using a personalized optimal position based on their 3D nasal replica. All participants irrigate their sinuses once daily with 2 mg mometasone in 240 mL NeilMed sinus rinse bottles for 8 weeks. During the study, participants complete symptom evaluations including the Nasal Obstruction Symptom Evaluation (NOSE) score, 22-item Sino-Nasal Outcome Test (SNOT-22), and Visual Analogue Scale (VAS) for nasal congestion at baseline and after 8 weeks of treatment. CT scans assess sinus inflammation using the Lund-Mackay (LM) score at the same time points. The study monitors patient adherence and collects data to evaluate whether personalized irrigation improves quality of life and nasal symptom relief over the 8-week treatment period.
CONDITIONS
3D Printing to Improve Nasal Irrigation Outcome
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants irrigate their sinuses once daily with 2 mg mometasone using 240 mL NeilMed sinus rinse bottles for 8 weeks. The head position during irrigation varies by group, including standard, backfill, or personalized 3D printed model-based positions.
1 baseline visit and 1 follow-up visit after 8 weeks
Total: 1 location
1
The Ohio State University Eye and Ear Institue
Columbus, Ohio, United States, 43212
Actively Recruiting
K
Kai Zhao, PhD
Z
Zachary T. Root, BS
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Silviu Albu
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https://pubmed.ncbi.nlm.nih.gov/32441708Zachary T Root, Thomas J Lepley, Kanghyun Kim...
https://pubmed.ncbi.nlm.nih.gov/39417152