Skip to main content
OpenTrials
Completed

NCT Number: NCT07730320

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..

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allama Iqbal Medical College/Jinnah Hospital Lahore

Lahore, Punjab Province, 55400, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PIEZO ELECTRIC DEVICE (PIEZOSURGERY)

Procedure

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.

GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOME

Procedure

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

Primary outcomes

  1. INTROPERATIVE BLOOD LOSS

    Time frame: DURING SURGERY from the start of osteotomy

    It 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

  2. Mean Duration of Surgery

    Time frame: During surgery from the start of maxillary vestibular incision till maxilla is disimpacted post bone osteotomy

    It was measured in minutes from the start of maxillary vestibular incision till the disimpaction of maxilla post bone osteotomy during surgery

Sponsors and collaborators

Lead sponsor

Allama Iqbal Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.