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Completed

NCT Number: NCT05807087

Comparison of Conventional Techniques & Piezosurgery in the Management of the Nasal Bony Pyramid

It is well-known and universally acknowledged that rhinoplasty is the most demanding procedure in facial aesthetic surgery. Postoperatively nasal osteotomies result in variable degrees of edema and ecchymosis and surgeons have tried various techniques, instruments, and postoperative methods to diminish these uncomfortable morbidities. Piezosurgery is used nowadays to decrease the incidence of injured soft tissues and vital structures passing near the osteotomy line. Its use in rhinoplasty was advocated to prevent unwanted back fractures as well as to decrease bleeding while keeping the nasal mucosa intact thus minimizing postoperative sequelae.

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Key information

Conditions

Nasal Injury

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requesting aesthetic rhinoplasty, post-traumatic rhinoplasty, and post-cleft nose rhinoplasty.

Exclusion criteria

  • Patients with severe systemic disease (American Society of Anesthesiologists physical status classification system III & IV).
  • Psychological disorders.
  • Female patients younger than 16 years of age and male patients younger than 18 years of age.
  • Patients with autoimmune and skin diseases.

Treatment and study plan

Conventional osteotomy

Procedure

The nasal skeleton was accessed using a closed approach or an open approach is done via a transcolumellar and infracartilaginous incision. Osteotomy was made using osteotomes.

Piezosurgery osteotomy

Procedure

full exposure of the nasal bony pyramid is needed.

Primary outcomes

  1. Operative time

    Time frame: During procedure

    Operation duration will be calculated

  2. Visual analogue score

    Time frame: immediately after procedure

    The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

  3. Change in periorbital edema

    Time frame: Baseline and 1 week

    Grade 1 - No coverage of iris with eyelids, Grade 2 - Slight coverage of iris with swollen eyelids, Grade 3 - Full coverage of iris with swollen eyelids, Grade 4 - Full closure of eyes.

  4. Change in eccyhmosis

    Time frame: Baseline and 1 week

    Grade 1 - Eccyhmosis upto the medial one-third part of lower and /or upper eyelid, Grade 2 - Ecchymosis upto the medial two-third part of the lower and/or upper eyelid. Grade 3 - Ecchymosis up to the full length and /or upper eyelid.

Secondary outcomes

  1. Functional - aesthetic outcome

    Time frame: immediately after procedure

    The SCHNOS is a 10-item self-rated questionnaire that uses a Likert-like 0-5 scale ('no problem' to 'extreme problem'). The SCHNOS does not produce a combined total score, but two scores - one for each domain, an obstruction score (SCHNOS-O) and a cosmesis score (SCHNOS-C) The SCHNOS-O is calculated as a sum of scores of items 1-4 divided by 20 and multiplied by 100. The SCHNOS-C score is calculated as a sum of scores of items 5-10 divided by 30 and multiplied by 100.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Prospective Randomized Study Between Conventional Techniques & Piezosurgery in the Management of Nasal Bony Pyramid

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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