An interventional study of Piezoelectric Surgical Device and Ultrasonic Bone Scalpel in Temporomandibular Joint Ankylosis, sponsored by Ankara University. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Ankara University · Not applicable, Interventional, and Treatment
Temporomandibular joint (TMJ) ankylosis is a condition in which the jaw joint becomes partially or completely fused, resulting in restricted mouth opening and difficulties with chewing, speaking, and daily activities. Surgical treatment aims to remove the ankylotic bone and restore normal jaw movement. Different bone-cutting devices can be used during surgery, but their effects on surgical efficiency, postoperative recovery, and quality of life may vary.
This prospective, non-randomized comparative clinical study aimed to compare three osteotomy techniques used in TMJ ankylosis surgery: piezoelectric surgery, an ultrasonic bone scalpel, and a conventional reciprocating saw.
A total of 32 patients undergoing TMJ ankylosis surgery were included. Eleven patients underwent surgery using a piezoelectric device, eleven using an ultrasonic bone scalpel, and ten using a conventional reciprocating saw. All surgical procedures were performed by the same surgeon under general anesthesia using a standardized surgical protocol.
The primary outcome was osteotomy time, measured during surgery. Secondary outcomes included total operative time, intraoperative blood loss, maximum mouth opening, postoperative pain, facial nerve function, and patient-reported quality of life. Facial nerve function was evaluated using the House-Brackmann grading system and the Sunnybrook Facial Grading System. Quality of life was assessed using the SF-12, WHOQOL-BREF, OHIP-14, and UW-QOL questionnaires.
Patients were followed for six months after surgery to evaluate functional recovery and changes in quality of life. The study aimed to determine whether the choice of osteotomy device was associated with differences in surgical efficiency, early postoperative recovery, and patient-reported outcomes.
Ankara University is the lead sponsor of 318 studies on the registry; 65 are open to participants now.
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Scheduled to undergo primary TMJ ankylosis surgery.
American Society of Anesthesiologists (ASA) physical status I or II.
Ability to comply with the postoperative follow-up protocol.
Provision of written informed consent.
Exclusion Criteria:
Active systemic infection or malignancy.
Rheumatologic or neuromuscular disorders.
Inability to complete the questionnaires because of psychiatric illness or cognitive impairment.
Long-term opioid or immunosuppressive therapy.
Incomplete clinical records.
Failure to complete the follow-up protocol.
Eleven patients underwent temporomandibular joint ankylosis surgery using a piezoelectric surgical device (Mectron Medical Technology, Italy).
Device: Piezoelectric Surgical Device
Eleven patients underwent temporomandibular joint ankylosis surgery using an ultrasonic bone scalpel (BoneScalpel, Misonix Inc., USA).
Device: Ultrasonic Bone Scalpel
Ten patients underwent temporomandibular joint ankylosis surgery using a conventional reciprocating saw (S-8 R, W\&H, Austria).
Device: Conventional Reciprocating Saw
A piezoelectric surgical device (Mectron Medical Technology, Italy) was used to perform osteotomy during temporomandibular joint ankylosis surgery. The device uses ultrasonic microvibrations to selectively cut mineralized bone tissue. Osteotomy was performed to facilitate removal of the ankylotic bone mass while minimizing injury to adjacent soft tissues. Eleven patients underwent surgery using this device.
Also known as: Mectron Piezoelectric Surgery Device
An ultrasonic bone scalpel (BoneScalpel, Misonix Inc., USA) was used to perform osteotomy during temporomandibular joint ankylosis surgery. The device uses ultrasonic vibrations for bone cutting and was applied to resect the ankylotic bone mass. Eleven patients underwent surgery using this device.
Also known as: BoneScalpel, Misonix
A conventional reciprocating saw (S-8 R, W\&H, Austria) was used to perform osteotomy during temporomandibular joint ankylosis surgery. The device uses a mechanically driven reciprocating blade to cut bone and facilitate resection of the ankylotic mass. Ten patients underwent surgery using this device.
Also known as: S-8 R, W&H
Osteotomy Time
Osteotomy time was defined as the time required to complete osteotomy for resection of the ankylotic bone mass. The duration was measured in seconds using a digital stopwatch, from the initiation to the completion of osteotomy. Osteotomy times were compared among the piezoelectric surgery, ultrasonic bone scalpel, and conventional reciprocating saw groups.
Time frame: Intraoperatively, during the index surgery.
Total Operative Time
Total operative time was recorded in minutes for each patient undergoing temporomandibular joint ankylosis surgery. Operative times were compared among the three osteotomy device groups.
Time frame: Intraoperatively, during the index surgery.
Plan to share: No — Individual participant data (IPD) will not be made publicly available to protect patient confidentiality and privacy. The study involves sensitive clinical and patient-reported outcome data. Data sharing is restricted in accordance with the ethical approval and informed consent procedures of the study.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Temporomandibular ankylosis