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The Evaluation of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty

The Evaluation of the Effect of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty by the Ultrasonic Measurement of Nasal Skin Thickness

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06094348
Enrollment
60
Registered
2023-10-23
Start date
2023-05-19
Completion date
2024-04-19
Last updated
2023-10-23

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

Conditions

Nasal Deformity, Acquired, Septum; Deviation, Congenital

Keywords

rhinoplasty, edema, piezosurgery, osteotomy

Brief summary

The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question\[s\] it aims to answer are: * In which osteotomy technique the edema is lesser? * Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster? Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively. Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements)

Detailed description

The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question\[s\] it aims to answer are: * In which osteotomy technique the edema is lesser? * Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster? 18-65 years old males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure will be included in the study. Patients who have a history of previous rhinoplasty/septorhinoplasty procedure, abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time), use of anticoagulant drugs, chronic / inflammatory skin disease and/or chronic skin allergies, systemic diseases (hypertension, diabetes mellitus, bronchial asthma), nasal beautification procedures such as dermal fillings, using oral and/or topical (nasal skin) corticosteroids in three months preoperatively will be excluded. Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively. Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements).

Interventions

PROCEDUREEndonasal osteotomy

Patients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome.

DEVICEPiezo assisted osteotomy

Piezo is a system for cutting bone with micrometric ultrasonic piezoelectric vibrations, with varying frequency and cutting energy. The device consists of a platform with a powerful piezoelectric hand piece and employs a functional frequency between 25-29 kHz. The device is fitted with a cooling irrigation system with a 0-60 cc/min variable sterile solution flow. Specific inserts and scalpels act in a linear vibration pattern, with a spatial range between 60 and 210 microns, moved by an ultrasonic power that exceeds 5 watts, reaching up to 16 watts.

Sponsors

Haseki Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* nasal respiratory dysfunction with the deviation of nasal septum and/or the nasal pyramid

Exclusion criteria

* previous rhinoplasty/septorhinoplasty procedure * patients with abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time) * use of anticoagulant drugs * chronic / inflammatory skin disease and/or chronic skin allergies * presence of systemic diseases (hypertension, diabetes mellitus, bronchial asthma) * nasal beautification procedures such as dermal fillings * use of oral and/or topical (nasal skin) corticosteroids in three months preoperatively

Design outcomes

Primary

MeasureTime frameDescription
the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month10 monthsthe mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10 th month will be done by ultrasonography at four anatomic locations; these locations are nasion, rhinion, supratip and tip

Countries

Turkey (Türkiye)

Contacts

Primary ContactIsil Taylan Cebi, M.D
drisiltaylan@hotmail.com00905072352256
Backup ContactAbdullah Karatas, Assoc. Prof
akrts2000@yahoo.ca00905326230218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026