Rhinoplasty TechniquesNCT07142525
Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty
A study testing Hybrid Osteoplasty and Traditional Osteotomy and Rasping in people with Rhinoplasty Techniques, run by University of Sulaimani at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinoplasty Techniques
- What is being tested?
- Hybrid Osteoplasty and Traditional Osteotomy and Rasping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary open rhinoplasty planned.
- Dorsal hump with bony or mixed component suitable for either technique.
- No prior nasal surgery or significant nasal trauma affecting dorsum.
- ASA I-III and fit for general anesthesia.
- Willing to provide written informed consent, including standardized photography.
- Able and willing to attend all follow-up visits through 12 months.
Who cannot join
- Revision rhinoplasty or prior osteotomy/osseocartilaginous work.
- Active infection, open lesions, or uncontrolled dermatologic conditions at operative field.
- Bleeding diathesis, platelet disorder, INR elevation, or anticoagulant/antiplatelet therapy that cannot be paused.
- Uncontrolled systemic disease (e.g., hypertension, diabetes) or ASA ≥ IV.
- Pregnancy or breastfeeding.
- Chronic isotretinoin use within past 6 months or long-term systemic corticosteroid use.
- Concurrent interventional study that may affect healing or outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aesthetic and Functional Outcomes Following Hybrid Osteoplasty Versus Traditional Osteotomy in Rhinoplasty: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Hybrid Osteoplasty, Traditional Osteotomy and Rasping
- Keywords
- Osteoplasty, Dorsal Hump, Rhinoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid OsteoplastyProcedure or surgery
Also called Drill-Assisted Dorsal Hump Reduction, Power-Assisted Osteoplasty, Burr 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.
Traditional Osteotomy and RaspingProcedure or surgery
Also called Osteotome + Rasp Technique, Conventional Dorsal Hump Reduction
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.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Osteoplasty | Experimental | Participants undergo dorsal hump reduction using a surgical burr (drill) without traditional dorsal osteotomy. The technique allows controlled bone contouring under direct visualization. Receives: Procedure: Hybrid Osteoplasty |
| Traditional Osteotomy and Rasping | Active comparator | Participants undergo dorsal hump reduction using the conventional method of osteotomy combined with rasping. This is the established standard approach for contouring the nasal dorsum. Receives: Procedure: Traditional Osteotomy and Rasping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Rhinoplasty Outcome Evaluation (ROE) Score from Baseline to 12 Months
ROE (Rhinoplasty Outcome Evaluation) questionnaire scored 0-100 (higher = greater satisfaction). Score calculated per instrument guidance from the 6 items, converted to 0-100. Change is 12-month minus preoperative score.
Measured: Baseline (preoperative) and 12 months post-operation.
Mean Dorsal Contour Irregularity Score on Blinded Photographic Assessment at 12 Months
Standardized 7-view photographs rated by three blinded surgeons using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe irregularity). Primary analysis compares group means; inter-rater agreement assessed.
Measured: 12 months post-operation.
Mean Periorbital Edema Score on 4-Point Clinician Scale at Day 1 and Day 7
3 Clinicians-rated 4-point edema scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Measured: Post-op Day 1 and Day 7.
Mean Periorbital Ecchymosis Score on 4-Point Clinician Scale at Day 1 and Day 7
3 Clinician-rated 4-point ecchymosis scale (0-3).
Measured: Post-op Day 1 and Day 7.
Proportion of Participants with Residual Hump or Dorsal Depression on Blinded Photographic Assessment at 12 Months
Blinded photographic assessment for remnant hump or depression (present/absent), by 3 assessors.
Measured: 12 months post-operation
Proportion of Participants with Nasal Dorsum Width Symmetry at 12 Months
Symmetry rated by 3 blinded assessors on 3-point scale (symmetric / mildly asymmetric / asymmetric)
Measured: 12 months post-operation
Number of Participants Requiring Unplanned Revision Surgery within 12 Months
Any unplanned surgical revision related to the nasal dorsum
Measured: Within 12 months post-operation
Secondary outcomes (4)
Proportion of Participants with Smooth Nasal Dorsum (Non-Blinded Binary Assessment) at 12 Months
Smooth vs Irregular, reported by 3 assessors
Measured: 12 months post-operation
Mean Change in Nasal Obstruction Symptom Evaluation (NOSE) Score from Baseline to 12 Months
NOSE questionnaire scored 0-100 (higher = worse obstruction). Change is 12-month minus preoperative score; negative values indicate improvement.
Measured: Baseline (preoperative) and 12 months post-operation.
Mean Pain Score on 0-10 Visual Analogue Scale at Post-Op Day 0 and Day 7
Pain measured on a 0-10 visual analogue scale (higher = more pain)
Measured: Post-op Day 0 and Day 7
Proportion of Participants with Palpable or Visible Dorsal Callus on Clinical Exam at 3 and 6 Months
Presence of palpable or visible dorsal callus on clinical exam (Yes/No). 3 assessors.
Measured: 3 and 6 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rhinoplasty TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Goran Latif Omer, University of Sulaimani
- Investigators
- Goran L Omer, PhD, Study chair, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142525
- Sponsor's protocol ID
- No. 159 (August 17th, 2025)
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the published results will be shared, including baseline demographic information, surgical technique allocation, intraoperative variables, and postoperative outcome measures (pain scores, edema, ecchymosis, ROE scores, NOSE scores, blinded photographic assessments, and revision status). Data will be available in de-identified form upon reasonable request to the principal investigator after publication of the primary results. Supporting documents, including the study protocol and statistical analysis plan, will also be made available.
Publications
Azizli E, Bayar Muluk N, Dundar R, Cingi C. A new preservation technique for dehumping the dorsum. Eur Rev Med Pharmacol Sci. 2023 Mar;27(2 Suppl):57-62. doi: 10.26355/eurrev_202303_31703.
PubMed 36971222Ferreira MG, Monteiro D, Reis C, Almeida e Sousa C. Spare Roof Technique: A Middle Third New Technique. Facial Plast Surg. 2016 Feb;32(1):111-6. doi: 10.1055/s-0035-1570503. Epub 2016 Feb 10.
PubMed 26862972Aldosari BF, Alhajress RI, Bogari AO. Hump Rasping Using Powered Instruments: A Retrospective Review. Plast Reconstr Surg Glob Open. 2024 Sep 10;12(9):e6153. doi: 10.1097/GOX.0000000000006153. eCollection 2024 Sep.
PubMed 39258281Lal GN, Ghosh P. Use of drill in rhinoplasty (a case report). Indian J Otolaryngol Head Neck Surg. 1999 Jan;51(1):90-2. doi: 10.1007/BF02996859.
PubMed 23119498Goodman WS. The rotating burr in rhinoplasty. Arch Otolaryngol. 1981 Jul;107(7):436-8. doi: 10.1001/archotol.1981.00790430038010. No abstract available.
PubMed 7247809Avashia YJ, Marshall AP, Allori AC, Rohrich RJ, Marcus JR. Decision-Making in Middle Vault Reconstruction following Dorsal Hump Reduction in Primary Rhinoplasty. Plast Reconstr Surg. 2020 Jun;145(6):1389-1401. doi: 10.1097/PRS.0000000000006850.
PubMed 32195860Barrett DM, Casanueva F, Wang T. Understanding Approaches to the Dorsal Hump. Facial Plast Surg. 2017 Apr;33(2):125-132. doi: 10.1055/s-0037-1598033. Epub 2017 Apr 7.
PubMed 28388791Fuller JC, Hilger PA. Modified Skoog Method for Hump Reduction. Facial Plast Surg Clin North Am. 2021 Feb;29(1):131-139. doi: 10.1016/j.fsc.2020.09.008.
PubMed 33220838Sowder JC, Thomas AJ, Gonzalez CD, Limaye NS, Ward PD. Use of Spreader Flaps Without Dorsal Hump Reduction and the Effect on Nasal Function. JAMA Facial Plast Surg. 2017 Jul 1;19(4):287-292. doi: 10.1001/jamafacial.2016.2057.
PubMed 28241228Azizzadeh B, Reilly M. Dorsal Hump Reduction and Osteotomies. Clin Plast Surg. 2016 Jan;43(1):47-58. doi: 10.1016/j.cps.2015.09.022. Epub 2015 Oct 23.
PubMed 26616694Roostaeian J, Unger JG, Lee MR, Geissler P, Rohrich RJ. Reconstitution of the nasal dorsum following component dorsal reduction in primary rhinoplasty. Plast Reconstr Surg. 2014 Mar;133(3):509-518. doi: 10.1097/01.prs.0000438453.29980.36.
PubMed 24263393Rohrich RJ, Muzaffar AR, Janis JE. Component dorsal hump reduction: the importance of maintaining dorsal aesthetic lines in rhinoplasty. Plast Reconstr Surg. 2004 Oct;114(5):1298-308; discussion 1309-12. doi: 10.1097/01.prs.0000135861.45986.cf.
PubMed 15457053