The use of internal nasal dilators to improve breathing and symmetry after rhinoplasty surgery

The functional and aesthetic effects of internal nasal dilator device use following septorhinoplasty: a randomized, single-blinded controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13835640

Enrollment

128

Registered

2025-11-04

Start date

2023-01-15

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative nasal obstruction and nostril asymmetry after septorhinoplasty (rhinoplasty). The study examines whether internal nasal dilators improve functional breathing outcomes and aesthetic nasal symmetry during postoperative healing. Surgery

Interventions

Participants in the intervention group received a soft, silicone internal nasal dilator inserted on postoperative Day 3 and worn continuously for 1 week, then nightly through 3 months, in addition to

Eligibility

Sex/Gender

All

Age

16 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 16–55 years undergoing primary open or closed septorhinoplasty (cosmetic, functional, or combined) 2. Provide informed consent 3. Able to complete questionnaires in English or French 4. Comply with scheduled follow-up visits at baseline, 3 and 12 months

Exclusion criteria

Exclusion criteria: 1. Cleft-related nasal deformities 2. Planned alar base reduction 3. Revision rhinoplasty 4. Prior nasal surgery 5. Psychiatric or cognitive disorders affecting compliance 6. Concurrent use of internal nasal stents 7. Active nasal infection 8. Silicone allergy 9. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Patient-reported nostril symmetry measured using a 5-point Likert scale (0 = perfectly symmetrical; 4 = very asymmetrical) at 3 and 12 months after septorhinoplasty	—

Secondary

Measure	Time frame
1. SCHNOS functional domain scores (nasal breathing) at baseline, 3, and 12 months. 2. SCHNOS aesthetic domain scores at baseline, 3, and 12 months. 3. Total SCHNOS score combining functional and aesthetic domains at baseline, 3, and 12 months. 4. Device comfort rated on a 10-point VAS at 1 week and 3 months. 5. Incidence of device-related or postoperative adverse events (irritation, ulceration, infection) through 12 months.	—

Measure

Time frame

1. SCHNOS functional domain scores (nasal breathing) at baseline, 3, and 12 months. 2. SCHNOS aesthetic domain scores at baseline, 3, and 12 months. 3. Total SCHNOS score combining functional and aesthetic domains at baseline, 3, and 12 months. 4. Device comfort rated on a 10-point VAS at 1 week and 3 months. 5. Incidence of device-related or postoperative adverse events (irritation, ulceration, infection) through 12 months.

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Countries

Canada

Contacts

Public ContactRaisa Chowdhury

raisa.chowdhury@mail.mcgill.ca5148063787

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026