Maxilla FractureNCT07730320
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..
A study testing PIEZO ELECTRIC DEVICE (PIEZOSURGERY) and GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOME in people with Maxilla Fracture and Malunited Maxilla Fracture, run by Allama Iqbal Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxilla Fracture, Malunited Maxilla Fracture
- What is being tested?
- PIEZO ELECTRIC DEVICE (PIEZOSURGERY) and GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOME
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2024to 2 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous Maxillofacial Treatment
- Lactating mothers and Pregnant Females
- Any Bone pathology or bone disease determined on Xray
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Medical College/Jinnah Hospital Lahore
Lahore, Punjab Province, 55400
About this study
Official title: OUTCOME OF PIEZOSURGERY IN LEFORT I OSTEOTOMY OF MAXILLARY OLD MALUNITED FRACTURES VERSUS CONVENTIONAL METHOD: A Randomized Clinical Study
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.
Read the 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.
- Conditions
- Maxilla Fracture, Malunited Maxilla Fracture
- Being tested
- PIEZO ELECTRIC DEVICE (PIEZOSURGERY), GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOME
- Medical subject headings
- Maxillary Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIEZO ELECTRIC DEVICE (PIEZOSURGERY)Procedure or surgery
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 OSTEOTOMEProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| GROUP A (PIEZOSURGERY) | Experimental | 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 Receives: Procedure: PIEZO ELECTRIC DEVICE (PIEZOSURGERY) |
| GROUP B ( Conventional Method) | Active comparator | 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 Receives: Procedure: GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOME |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During surgery from the start of maxillary vestibular incision till maxilla is disimpacted post bone osteotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start4 Mar 2024
- Primary completion29 Aug 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxilla FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maham Azam, Allama Iqbal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730320
- Sponsor's protocol ID
- 281/21/07/2022/S1 ERB
- Status last verified
- Mar 2024
- First submitted
- 12 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Labanca M, Azzola F, Vinci R, Rodella L. Piezoelectric surgery: twenty years of use. Br J Oral Maxillofac Surg. 2008;46:265-269. 2. Gülnahar Y, Kösger H, Tutar Y. Comparison of piezosurgery and conventional surgery by heat shock protein 70 expression. Int J Oral Maxillofac Surg. 2013;42:508-510. 3. Pavlíková G, Foltán R, Burian M, et al. Piezosurgery prevents brain tissue damage: experimental study. Int J Oral Maxillofac Surg. 2011;40:840-844. 4. Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004;53:207-214.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OUTCOME OF PIEZOSURGERY IN LEFORT I OSTEOTOMY OF MAXILLARY OLD MALUNITED FRACTURES VERSUS CONVENTIONAL METHOD: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07730320
- Acronym / sponsor ID
- 281/21/07/2022/S1 ERB
- Conditions
- Maxilla Fracture, Malunited Maxilla Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Allama Iqbal Medical CollegeUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GROUP A (PIEZOSURGERY) | Experimental | Procedure: PIEZO ELECTRIC DEVICE (PIEZOSURGERY)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 |
| GROUP B ( Conventional Method) | Active comparator | Procedure: GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOMEGroup 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 |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Previous Maxillofacial Treatment
- Lactating mothers and Pregnant Females
- Any Bone pathology or bone disease determined on Xray
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIEZO 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. | Procedure or surgery | GROUP A (PIEZOSURGERY) |
| GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOMEIn 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 | Procedure or surgery | GROUP B ( Conventional Method) |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background1. Labanca M, Azzola F, Vinci R, Rodella L. Piezoelectric surgery: twenty years of use. Br J Oral Maxillofac Surg. 2008;46:265-269. 2. Gülnahar Y, Kösger H, Tutar Y. Comparison of piezosurgery and conventional surgery by heat shock protein 70 expression. Int J Oral Maxillofac Surg. 2013;42:508-510. 3. Pavlíková G, Foltán R, Burian M, et al. Piezosurgery prevents brain tissue damage: experimental study. Int J Oral Maxillofac Surg. 2011;40:840-844. 4. Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004;53:207-214.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIEZO ELECTRIC DEVICE (PIEZOSURGERY) and GROUP B CONVENTIONAL METHOD ( Mallet and OSTEOTOME in people with Maxilla Fracture and Malunited Maxilla Fracture, run by Allama Iqbal Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INTROPERATIVE BLOOD LOSS (time frame: DURING SURGERY from the start of osteotomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07730320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.