Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06118554

3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical Trial

Led by Ohio State University · Updated on 2026-05-26

200

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

3D Printing to Improve Nasal Irrigation Outcome

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • Diagnosis of chronic rhinosinusitis with or without nasal polyps
Not Eligible

You will not qualify if you...

  • Presence of significant nasal polyps as determined by a clinician
  • Significant atopy
  • Cystic fibrosis
  • Granulomatosis with polyangiitis or other connective tissue disorders
  • Current pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Trial Site Locations

Total: 1 location

1

The Ohio State University Eye and Ear Institue

Columbus, Ohio, United States, 43212

Actively Recruiting

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Research Team

K

Kai Zhao, PhD

Z

Zachary T. Root, BS

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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Published Research Related To This Trial

A multicenter survey on the effectiveness of nasal irrigation devices in rhinosinusitis patients.

Patorn Piromchai, Charoiboon Puvatanond, Virat Kirtsreesakul...

https://pubmed.ncbi.nlm.nih.gov/33364388