An interventional study of PIEZO ELECTRIC DEVICE (PIEZOSURGERY) and GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOME in Maxilla Fracture and Malunited Maxilla Fracture, sponsored by Allama Iqbal Medical College. Completed at 1 site in Pakistan. Open to participants aged 15 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Allama Iqbal Medical College · Not applicable, Interventional, and Other
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.
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.
Allama Iqbal Medical College is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Piezoelectric surgical devices are tools based on ultrasonic microvibrations that are utilized for precise bone cutting and low risk to the surrounding soft tissues, thereby decreasing intraoperative blood loss and Duration of surgery. In one ARM ( GROUP A) , all those patients having maxillary old Malunited fractures, Lefort I osteostomy will be performed with piezoelectric device
Procedure: PIEZO ELECTRIC DEVICE (PIEZOSURGERY)
Group B osteotomy will be performed in patients having old Malunied Maxillary fractures with rotary bur and then chisel/mallet which is conventional method. This method increases duration of surgery as well as intraoperative blood loss
Procedure: GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOME
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.
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
INTROPERATIVE BLOOD LOSS
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
Time frame: DURING SURGERY from the start of osteotomy
Mean Duration of Surgery
It was measured in minutes from the start of maxillary vestibular incision till the disimpaction of maxilla post bone osteotomy during surgery
Time frame: During surgery from the start of maxillary vestibular incision till maxilla is disimpacted post bone osteotomy
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Maxillary Fractures
Allama Iqbal Medical College