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External perforating osteotomy in rhinoplasty with ultrasonic cut

External perforating osteotomy in rhinoplasty comparing ultrasonic cut vs traditional osteotome: A preliminary randomized crossover clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220104053618N1
Enrollment
26
Registered
2022-09-23
Start date
2022-09-17
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

nose deformity. Congenital malformation of nose, unspecified

Interventions

Intervention 1: Intervention group: Lateral osteotomy using Action piezoelectric device made in France on a sample of 26 person under general anesthesia after 7-10 minutes of injection of lidocaine co
The first incision will be made in the caudal area and the second incision will be made 8-10 mm more medial than the medial canthus without lifting the periosteum. Intervention 2: In the control side,

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: age over18 years old patients without any diseases

Exclusion criteria

Exclusion criteria: history of rhinoplasty deviation respiratory problems narrow dorsum

Design outcomes

Primary

MeasureTime frame
Eyelid ecchymosis. Timepoint: Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation. Method of measurement: Kara and Gökalan classification system for ecchymosis: grade 1: ecchymosis of the medial third of the upper or lower eyelid or both - grade 2: bruising of the medial two thirds of the upper or lower eyelid or both - grade 3: bruising of the entire length of the upper or lower eyelid or both.;Eyelid edema. Timepoint: Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation. Method of measurement: Kara and Gökalang's classification system for swelling: Grade 1: no pupil covering interference by Hagrid's eyelids - 2: little pupil covering by eyelid swelling - Grade 3: complete pupil covering by significant swelling of Hagrid's eyelids 4: complete closure of the eyes.;Subconjunctival hemorrhage. Timepoint: Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation. Method of measurement: Classification system for open and Gökalan Subconjunctival hemorrhage: grade 1: presence of Subconjunctival hemorrhage up to 50% of the congeal surface - grade 2: presence of Subconjunctival hemorrhage with 90% of the congeal surface.;Pain. Timepoint: Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation. Method of measurement: Pain will be evaluated using a visual analog scale (VAS), in this way, the patient will be given a line marked from 0 to 10, and during three days, he will mark his pain level on the right and left side separately. It means that the number 0 indicates no pain and 10 is the highest value.;Bleeding. Timepoint: During the operation and immediately post operation. Method of measurement: visual.;Scar. Timepoint: Skin scars will be evaluated one month after surgery. Method of measurement: The two sides will be compared visually.;Force for the mobilization of n

Countries

Iran (Islamic Republic of)

Contacts

Public Contact????? ??????

Ahvaz University of Medical Sciences

Bahareh_yaghoobi@yahoo.com+98 21 3223 4448

Outcome results

None listed

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