NCT05202444

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

January 9, 2022

Last Update Submit

January 9, 2022

Conditions

Maxillofacial, Osteotomy

Outcome Measures

Primary Outcomes (2)

  • Intra-operative Bleeding

    From begining of the surgery till the end

  • Osteotomy Time

    From begining of the surgery till the end

Study Arms (2)

Osteotomy using piezoelectrical device

EXPERIMENTAL
Procedure: Osteotomy using piezoelectrical device

Osteotomy using surgical saw

ACTIVE COMPARATOR
Procedure: Osteotomy using piezoelectrical device

Interventions

Osteotomy using piezoelectrical devicePROCEDURE

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 piezoelectrical deviceOsteotomy using surgical saw

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Minia University

Minya, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 9, 2022

First Posted

January 21, 2022

Study Start

November 1, 2019

Primary Completion

September 5, 2020

Study Completion

March 20, 2021

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

EG(1)