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The Aim of This Study is to Compare the Outcome of Piezosurgery Versus Conventional Osteotomy in Maxillary Old Malunited Fractures in Terms of Intraoperative Blood Loss and Duration of Surgery..

OUTCOME OF PIEZOSURGERY IN LEFORT I OSTEOTOMY OF MAXILLARY OLD MALUNITED FRACTURES VERSUS CONVENTIONAL METHOD: A Randomized Clinical Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07730320
Enrollment
60
Registered
2026-07-28
Start date
2024-03-04
Completion date
2024-09-02
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malunited Maxilla Fracture, Maxilla Fracture

Brief summary

To compare the outcomes of piezosurgery and conventional osteotomy in Le Fort I osteotomy for old malunited maxillary fractures in terms of mean duration of surgery and intraoperative blood loss.

Detailed description

The development of Piezosurgery was fueled by the need for greater precision and safety in bone surgery than when the standard bur and saw are used. Ultrasonic vibrations have been used to cut tissue for two decades .However, it is only in the last 18 years that it has been used routinely for standard clinical applications in many different fields of surgery. Piezosurgery decreases the risk of damage to the surrounding soft tissues and critical structures (nerves, vessels, and mucosa), particularly during an osteotomy. Although, in theory, execution of the osteotomy itself is faster if made with the reciprocating saw, the total surgical time is actually shorter when a piezoelectric device is used because less maneuvers to protect the soft tissues are required and a clearer surgical field and increased visibility is produced. Microvibrations of 60 to 200 m/s at 24 to 29 kHz are applied to cut in mineralized tissue while soft tissue remains unharmed.The literature reports the following possible causes of post bilateral sagittal split osteotomy facial nerve injury direct trauma to the nerve by the osteotomy, direct trauma to the nerve when the mandibular ramus is moved posterior, and postoperative hematoma at the operation site causing pressure necrosis of the nerve. The objective of the present study was to compare the outcome of Piezosurgery in Lefort I osteotomy of patients having old Malunited Lefort I maxillary fracture as compared to the conventional method in terms of mean operative time and intraoperative blood loss. In this regard, the present survey was conducted from the patients of Department of Oral and Maxillofacial Surgery, Allama Iqbal Medical College, Lahore. Therefore, 60 patients were included by using non-probability consecutive sampling who were undergoing dental treatment after fulfilling the inclusion criteria.

Interventions

PROCEDUREPIEZO ELECTRIC DEVICE (PIEZOSURGERY)

Previously for various maxillofacial procedures osteotomy was performed with rotary burs, In our study patients with Old Malunited Maxillary Fractures , osteotomy will be performed with PIezoelectric device.

PROCEDUREGROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOME

In group B Intraoperative blood loss and mean duration of surgery will be measured after perfoming Lefort I osteotomy in patients having Maxillary Old Malunited fractures using bur and chisel/mallet. outcomes wiil be compared with Group A

Sponsors

Allama Iqbal Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Study Model comprise of two arms. In Group A patients having Old Malunited Maxillary Fractures their osteotomy will be done with Piezoelectric device whereas In Group B for such patients osteotomy will be planned with Conventional method using rotary bur and chisel/mallet. Duration of surgery and intraoperative blood loss will be compared in both ARMS.

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Malunited Lefort I Fracture of Maxilla for more than three weeks old * Untreated Maxillary Fractures. * Lefort I fracture on CT SCAN FACE with 3D reconstruction * Individuals with ASA1 and ASA2

Exclusion criteria

* Previous Maxillofacial Treatment * Lactating mothers and Pregnant Females * Any Bone pathology or bone disease determined on Xray

Design outcomes

Primary

MeasureTime frameDescription
INTROPERATIVE BLOOD LOSSDURING SURGERY from the start of osteotomyIt was measured in millilitres of increase in irrigation fluid collected during surgery and subtracting the amount of irrigation fluid from the total volume of blood and fluid in the suction bottle. it was classified as low 300 cc medium 400cc high 500cc or more
Mean Duration of SurgeryDuring surgery from the start of maxillary vestibular incision till maxilla is disimpacted post bone osteotomyIt was measured in minutes from the start of maxillary vestibular incision till the disimpaction of maxilla post bone osteotomy during surgery

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026