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

NCT ID: NCT05807087

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-09-16

Brief Summary

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.

Conditions

Nasal Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mechanical Osteotomy

Group Type: ACTIVE_COMPARATOR

Conventional osteotomy

Intervention Type: 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

Group Type: EXPERIMENTAL

Piezosurgery osteotomy

Intervention Type: PROCEDURE

full exposure of the nasal bony pyramid is needed.

Interventions

Conventional osteotomy

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.

Intervention Type: PROCEDURE

Piezosurgery osteotomy

full exposure of the nasal bony pyramid is needed.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Alexandria, Azarita, Egypt

Countries

Egypt

Other Identifiers

NasalBoneSurgery_2021

Identifier Type: -

Identifier Source: org_study_id