A comparative study of three methods of nasal irrigation.
Peter-John Wormald, Tim Cain, Lyndell Oates...
https://pubmed.ncbi.nlm.nih.gov/15564850/Actively 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
K
Kai Zhao, PhD
Z
Zachary T. Root, BS
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Ohio State University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | 3D Model-Guided Irrigation | Backfill-Guided Irrigation | Standard Irrigation |
|---|---|---|---|
| What it is | Personalized head positions for sinus irrigation determined by individualized 3D printed sinonasal models are used to optimize corticosteroid delivery for chronic rhinosinusitis. | A backfill head position protocol is applied to facilitate sinus irrigation, using specific head adjustments to encourage solution distribution for patients with chronic rhinosinusitis. | Standard sinus irrigation is performed using fixed head position, with mometasone delivered once daily via NeilMed sinus rinse for chronic rhinosinusitis. |
| Role in trial | Serves as an experimental arm to test whether tailored head positions based on 3D anatomical models improve irrigation outcomes. | Functions as an experimental arm testing a protocol-driven head position technique to optimize irrigation. | Acts as the active comparator arm to benchmark standard irrigation against personalized strategies. |
| Primary use | Optimizing delivery of topical corticosteroids for chronic rhinosinusitis using anatomic guidance to potentially improve symptom relief. | Facilitates effective irrigation within sinus cavities by adopting a protocol head position, with the goal of maximizing mometasone access to target tissues. | Delivers topical corticosteroids using conventional irrigation, providing a reference point for symptom improvement in routine care. |
| How it is given or performed | Irrigation is performed once daily for 8 weeks, guided by patient-specific 3D printed models to inform optimal head position. Mometasone is delivered via NeilMed sinus rinse bottles. | Irrigation is done once daily for 8 weeks, using a prescribed backfill head position technique. Delivery method and mometasone dose match the other groups. | Standard irrigation is performed once daily for 8 weeks in a fixed head position. Mometasone is delivered using NeilMed sinus rinse bottles. |
| Evidence status | Published pilot clinical trials suggest 3D model-guided irrigation may improve topical drug delivery, but larger definitive studies are needed to confirm sustained symptom benefit. | Direct clinical trial evidence for protocol-driven backfill head position is limited; current investigation aims to establish its impact on irrigation outcomes. | Standard irrigation has published evidence supporting its effectiveness for symptom improvement and is widely used in routine practice. |
| Important limitations | Requires individualized 3D printed models, which may add cost and complexity to routine care. Evidence is limited to pilot studies and small sample sizes. | Clinical impact and reproducibility of the backfill head position technique are not yet clearly established in published literature. | While effective for many patients, standard irrigation does not tailor delivery to individual anatomy and may be less optimal for reaching target sinuses in complex cases. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/36704822/Ohio State University
Lead Sponsor