The Use of Piezoelectric Surgery for Osteotomies

Evaluation of Using Piezoelectric Device Versus Conventional Saw for Osteotomy in Maxillary Orthognathic Surgery

Piezo-surgery was first used in oral and maxillofacial surgery in 2001 by Vercellotti and colleagues to simplify maxillary sinus surgery by avoiding perforation of the schneiderian membrane. Later on ultrasonic bone cutting has been used in orthognathic procedures, extraction of impacted third molars , cyst enucleation, implant site preparation, temporomandibular join surgery , corticotomy-facilitated orthodontics, and head and neck oncological and reconstructive surgeries.

Study Overview

• Status: Completed
• Conditions: Maxillofacial, Osteotomy
• Intervention / Treatment: Procedure: Osteotomy using piezoelectrical device

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Faculty of dentistry, Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ranged from 18 to 35 years.
2. Patients were not suffering from systemic diseases that compromise wound or bone healing.
3. Patients indicated for leforte I or maxillary subapical osteotomy.
4. Patients agree the informed consent .

Exclusion Criteria:

1. Patients suffering from systemic disease that may affect bleeding or bone healing
2. Syndromicdentofacial deformity patients.
3. Patients were subjected to previous maxillary orthognathic surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteotomy using piezoelectrical device	Procedure: Osteotomy using piezoelectrical device; osteotomy were utilized using piezoelectric from device (Woodpeker) with its internal irrigation system. We used US2 tip using the maximum bone cutting program and maximum irrigation program for lateral maxillary wall osteotomy and USIR tip for the posterior maxillary wall osteotomy. The pterygoid osteotome was placed between the tuberosity and pterygoid plates while the hamulus is palpated palatally with the index finger to guide the osteotome direction preventing palatal perforation.With the pterygoid osteotome still in position, we used a thin osteotome to complete the osteotomy of the posterior wall of the maxilla.
Active Comparator: Osteotomy using surgical saw	Procedure: Osteotomy using piezoelectrical device; osteotomy were utilized using piezoelectric from device (Woodpeker) with its internal irrigation system. We used US2 tip using the maximum bone cutting program and maximum irrigation program for lateral maxillary wall osteotomy and USIR tip for the posterior maxillary wall osteotomy. The pterygoid osteotome was placed between the tuberosity and pterygoid plates while the hamulus is palpated palatally with the index finger to guide the osteotome direction preventing palatal perforation.With the pterygoid osteotome still in position, we used a thin osteotome to complete the osteotomy of the posterior wall of the maxilla.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intra-operative Bleeding	From begining of the surgery till the end
Osteotomy Time	From begining of the surgery till the end

Collaborators and Investigators

• Sponsor: Minia University
• Collaborators: Dar Al Shifa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): September 5, 2020
• Study Completion (Actual): March 20, 2021

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: January 9, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 281 (Other Identifier: Faculty of Pharmacy Ain Shams University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No