The Use of Piezoelectric Surgery for Osteotomies

NCT ID: NCT05202444

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Maxillofacial, Osteotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Osteotomy using piezoelectrical device

Group Type EXPERIMENTAL

Osteotomy using piezoelectrical device

Intervention Type PROCEDURE

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.

Osteotomy using surgical saw

Group Type ACTIVE_COMPARATOR

Osteotomy using piezoelectrical device

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dar Al Shifa Hospital

OTHER

Sponsor Role collaborator

Minia University

OTHER

Sponsor Role lead

Responsible Party

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Abdullah Hammuda

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Minia University

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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281

Identifier Type: -

Identifier Source: org_study_id

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