- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07446426
Unilateral Septal Extension Graft and Bilateral Septal Extension Graft in Droopy Tip and Its Effect on Tip Deviation
Comparison Between Unilateral Septal Extension Graft and Bilateral Septal Extension Graft in Droopy Tip and Its Effect on Tip Deviation
Study Overview
Status
Intervention / Treatment
Detailed Description
The Nasal tip from an aesthetic perspective is one of the most visible nd defining features of the nose, Even with a well- shaped dorsum; a droopy, asymmetric or poorly supported tip can distort the overall appearance of the nose; as it play a key role in projection and rotation -the primary parameters that contribute to nasal attractiveness . Functionally the nasal tip is structurally essential for maintaining airway patency, A weak or collapsed tip can result in external nasal valve collapse leading to breathing issues .
The nasal tip is supported by several mechanisms including: the length and integrity of the lower lateral cartilages, the medial crural attachment to the septal cartilage, the connection to the upper lateral and lower lateral cartilages, the nasal membranous and cartilaginous septum, the anterior nasal spine, and the lateral crural attachment to the nasal aperture , Tip plasty is crucial as it ensures that the nose not only appears proportionate and aesthetically pleasing, but also functions properly, and maintains long-term structural support. Neglecting the nasal tip can result in an unnatural or imbalanced outcome even when the rest of the nose is well-shaped .
In primary rhinoplasty, the nasal tip is often the centeral cus for achieving a refined yet natural look. Tip plasty often includes several mechanisms such as (e.g., Colum umellar strut graft, septal extensions graft these are used to support or reposition the tip without compromising function. The Septal Extension Graft is considered one of the most reliable technique offering a wide range of applications. However, it may be associated with some drawbacks such as the tip's stiffness and potential aesthetical or functional issues. This study aims to compare between the unilateral and bilateral septal extension graft and evaluate the effect of each of them on tip deviation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yousef Elfert, Resident
- Phone Number: +20 10 69690777
- Email: Yousef192356_pg@med.tanta.edu.eg
Study Contact Backup
- Name: Yousef Elfert, Resident
- Phone Number: +20 10 69690777
Study Locations
-
-
-
Tanta, Egypt
- Tanta University
-
Contact:
- Yousef Elfert, Resident
- Phone Number: +20 10 69690777
- Email: Yousef192356_pg@med.tanta.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients above 18years
- Aesthetic complain related to nasal tip
- presented for primary rhinoplast.
Exclusion Criteria:
- Patients under 18year old
- Patients need extensive nasal reconstructions lacking septal cartilage
- Patients with severely deficient cartilaginous septum.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: unilateral septal extension graft
seventeen patients will undergo unilateral septal extension graft
|
Seventeen patients will undergo unilateral septal extension graft
|
|
Experimental: Bilateral septal extension graft
Seventeen will undergo bilateral septal extension graft
|
Seventeen will undergo bilateral septal extension graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arabic Rhinoplasty Outcome Evaluation Questionnaire
Time Frame: 3 months
|
Patient satisfaction with primary septorhinoplasty will be assessed using the Arabic Rhinoplasty Outcome Evaluation Questionnaire.
Validated Arabic Rhinoplasty Outcomes Evaluation questionnaire is a 6-item, self-report tool (0-24 scale) assessing physical, emotional, and social satisfaction after nasal surgery, with higher scores (0-100%) indicating better outcomes.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Deviation angle
Time Frame: 3 months after the operation
|
3 months after the operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 36264MS1042/8/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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