Temporomandibular Joint AnkylosisTMJ-OSTNCT07883889
Comparison of Three Osteotomy Techniques in Temporomandibular Joint Ankylosis Surgery
A study testing Piezoelectric Surgical Device, Ultrasonic Bone Scalpel and Conventional Reciprocating Saw in people with Temporomandibular Joint Ankylosis, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Joint Ankylosis
- What is being tested?
- Piezoelectric Surgical Device, Ultrasonic Bone Scalpel and Conventional Reciprocating Saw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2022to 20 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Ankara, 06560
About this study
Official title: Comparison of Ultrasonic Bone Scalpel, Piezoelectric Surgery and Conventional Reciprocating Saw in Temporomandibular Joint Ankylosis Surgery: Surgical Efficiency, Functional Recovery and Patient-Reported Outcomes
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.
Read more
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.
- Conditions
- Temporomandibular Joint Ankylosis
- Being tested
- Piezoelectric Surgical Device, Ultrasonic Bone Scalpel, Conventional Reciprocating Saw
- Medical subject headings
- Temporomandibular ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezoelectric Surgical DeviceDevice
Also called 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 ScalpelDevice
Also called 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 SawDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Piezoelectric Surgery | Experimental | Eleven patients underwent temporomandibular joint ankylosis surgery using a piezoelectric surgical device (Mectron Medical Technology, Italy). Receives: Device: Piezoelectric Surgical Device |
| Ultrasonic Bone Scalpel | Experimental | Eleven patients underwent temporomandibular joint ankylosis surgery using an ultrasonic bone scalpel (BoneScalpel, Misonix Inc., USA). Receives: Device: Ultrasonic Bone Scalpel |
| Conventional Reciprocating Saw | Active comparator | Ten patients underwent temporomandibular joint ankylosis surgery using a conventional reciprocating saw (S-8 R, W\&H, Austria). Receives: Device: Conventional Reciprocating Saw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperatively, during the index surgery.
Secondary outcomes (1)
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.
Measured: Intraoperatively, during the index surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start20 Apr 2022
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint AnkylosisStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Emre Yurttutan, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883889
- Sponsor's protocol ID
- AU-TMJ-OST-2022-01
- Other IDs
- TSG-2023-2856, 10/05
- Acronym
- TMJ-OST
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasonic Bone Scalpel, Piezoelectric Surgery and Conventional Reciprocating Saw in Temporomandibular Joint Ankylosis Surgery: Surgical Efficiency, Functional Recovery and Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT07883889
- Acronym / sponsor ID
- TMJ-OST / AU-TMJ-OST-2022-01
- Conditions
- Temporomandibular Joint Ankylosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 20 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Piezoelectric Surgery | Experimental | Device: Piezoelectric Surgical DeviceEleven patients underwent temporomandibular joint ankylosis surgery using a piezoelectric surgical device (Mectron Medical Technology, Italy). |
| Ultrasonic Bone Scalpel | Experimental | Device: Ultrasonic Bone ScalpelEleven patients underwent temporomandibular joint ankylosis surgery using an ultrasonic bone scalpel (BoneScalpel, Misonix Inc., USA). |
| Conventional Reciprocating Saw | Active comparator | Device: Conventional Reciprocating SawTen patients underwent temporomandibular joint ankylosis surgery using a conventional reciprocating saw (S-8 R, W\&H, Austria). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Piezoelectric Surgical DeviceAlso: Mectron Piezoelectric Surgery DeviceA 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. | Device | Piezoelectric Surgery |
| Ultrasonic Bone ScalpelAlso: BoneScalpel, MisonixAn 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. | Device | Ultrasonic Bone Scalpel |
| Conventional Reciprocating SawAlso: S-8 R, W&HA 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. | Device | Conventional Reciprocating Saw |
Primary outcome
Osteotomy Time
Time frame: 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.
1 secondary outcome
Total Operative Time
Time frame: Intraoperatively, during the index 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 20 Oct 2026.
- Individual participant dataSharing planned: 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.
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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 Piezoelectric Surgical Device, Ultrasonic Bone Scalpel and Conventional Reciprocating Saw in people with Temporomandibular Joint Ankylosis, run by Ankara University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 20 Oct 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 Turkey (Türkiye). 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?
Osteotomy Time (time frame: Intraoperatively, during the index surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.