NCT07142525

Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty

Aesthetic and Functional Outcomes Following Hybrid Osteoplasty Versus Traditional Osteotomy in Rhinoplasty: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Sulaimani · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare two common techniques for reducing the nasal hump during rhinoplasty: the traditional method using osteotomes and rasps, and a newer technique called hybrid osteoplasty that uses a surgical drill. Both approaches aim to improve the appearance and function of the nose. The trial will measure pain, swelling, bruising, and the smoothness of the nasal bridge, as well as patient satisfaction and breathing outcomes. Participants will be followed for one year to assess both early healing and long-term results.

Detailed description

This prospective randomized controlled trial will evaluate the aesthetic and functional outcomes of hybrid osteoplasty using a surgical burr compared with traditional osteotomy and rasping in primary open rhinoplasty patients presenting with dorsal humps. The study population consists of adults without prior nasal surgery, trauma, or congenital deformities. Patients are randomized into two groups: Group A (hybrid osteoplasty) and Group B (traditional osteotomy plus rasping). The primary objective is to assess differences in postoperative pain, edema, ecchymosis, dorsal smoothness, contour regularity, and patient satisfaction. Secondary outcomes include functional improvement measured by the Nasal Obstruction Symptom Evaluation (NOSE) score, aesthetic satisfaction assessed by the Rhinoplasty Outcome Evaluation (ROE), and the rate of revision surgery within 12 months. Follow-up assessments are scheduled on postoperative Days 1, 2, and 7, and at 1, 3, 6, and 12 months. Standardized photographic documentation will support aesthetic evaluation, while clinical scoring systems will provide objective and subjective outcome data. The trial is powered to identify whether hybrid osteoplasty offers advantages in contour refinement and reduced soft tissue trauma compared with conventional osteotomy-based approaches.

Conditions

• Rhinoplasty Techniques

Interventions

Type	Name	Description
PROCEDURE	Hybrid Osteoplasty	Open rhinoplasty with dorsal hump reduction performed using a powered surgical burr under irrigation and direct visualization. Bone is contoured gradually to achieve a smooth dorsum while preserving the keystone area. No dorsal osteotomy is performed in this arm. Cartilaginous work and adjunctive steps (e.g., septoplasty or tip refinement) are performed as clinically indicated but are not part of the intervention being tested.
PROCEDURE	Traditional Osteotomy and Rasping	Open rhinoplasty using the conventional technique for dorsal hump reduction. The bony hump is resected with a straight osteotome, followed by manual rasping to refine the nasal dorsum, with preservation of the keystone area. Powered burrs are not used for primary dorsal contouring in this arm. Cartilaginous work and adjunctive procedures may be performed as clinically indicated but are not part of the tested intervention.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-08-26
• Last updated: 2025-10-02

Locations

1 site across 1 country: Iraq