Comparison of Three Osteotomy Techniques in Temporomandibular Joint Ankylosis Surgery

NCT07883889 — Not applicable, Completed, 32 participants, Ankara University

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Comparison of Ultrasonic Bone Scalpel, Piezoelectric Surgery and Conventional Reciprocating Saw in Temporomandibular Joint Ankylosis Surgery: Surgical Efficiency, Functional Recovery and Patient-Reported Outcomes

Registry	NCT07883889, acronym TMJ-OST
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: single, treatment
Enrollment	32 (Actual)
Sponsor	Ankara University (Other)
Conditions	Temporomandibular Joint Ankylosis
Interventions	Piezoelectric Surgical Device, Ultrasonic Bone Scalpel, Conventional Reciprocating Saw (Device)
Dates	start 2022-04-20, primary completion 2026-01-20, completion 2026-01-20, first posted 2026-10-20, last updated 2026-10-20
Locations	1 site in Turkey (Türkiye)

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Piezoelectric Surgery	Experimental	Device: Piezoelectric Surgical Device	Eleven patients underwent temporomandibular joint ankylosis surgery using a piezoelectric surgical device (Mectron Medical Technology, Italy).
Ultrasonic Bone Scalpel	Experimental	Device: Ultrasonic Bone Scalpel	Eleven patients underwent temporomandibular joint ankylosis surgery using an ultrasonic bone scalpel (BoneScalpel, Misonix Inc., USA).
Conventional Reciprocating Saw	Active comparator	Device: Conventional Reciprocating Saw	Ten patients underwent temporomandibular joint ankylosis surgery using a conventional reciprocating saw (S-8 R, W\&H, Austria).

Piezoelectric Surgical Device (Device), also known as Mectron Piezoelectric Surgery Device: 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.
Ultrasonic Bone Scalpel (Device), also known as BoneScalpel, Misonix: 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.
Conventional Reciprocating Saw (Device), also known as S-8 R, W&H: 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.

+Outcome measures

Primary outcomes

Osteotomy Time [Intraoperatively, during the index surgery.]: 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.

Secondary outcomes

Total Operative Time [Intraoperatively, during the index surgery.]: 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.

+Eligibility

Sex: All

Inclusion Criteria:

* Clinical and cone-beam computed tomography (CBCT)-confirmed diagnosis of temporomandibular joint (TMJ) ankylosis.

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:

* Recurrent TMJ ankylosis.

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.

+Locations (1)

Facility	City	Country	Status
Ankara University Faculty of Dentistry	Ankara, Ankara	Turkey (Türkiye)