Bilateral Temporomandibular Joint DisorderNCT05027243
Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results
A study testing bilateral temporomandibular joint arthroscopy and Xeomin® (Merz) in people with Bilateral Temporomandibular Joint Disorder, run by Instituto Portugues da Face.
Trial summary
Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bilateral Temporomandibular Joint Disorder
- What is being tested?
- bilateral temporomandibular joint arthroscopy and Xeomin® (Merz)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2016to 31 Jul 2021
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- age >16 years;
- clinical diagnosis of bilateral intra-articular disorder;
- clinical criteria for bilateral TMJ arthroscopy;
- magnetic resonance imaging (MRI) assessing the intra-articular derangement
Who cannot join
- The exclusion criteria included any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks prior the study.
- Severe medical problems or mental illness, and pregnancy were also exclusion criteria
About this study
Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.
Read the detailed description
Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. It was first introduced by Onishi at 1975, as a pioneering technique to treat painful joints and has been associated with a reduction in the number of open joints surgeries. This minimally invasive technique allows observation of the TMJ upper compartment tissues, and sometimes the lower compartment. Moreover, this intervention allows joint lysis and lavage (level 1 arthroscopy) and intra-articular surgical procedures (level 2-3 arthroscopy).
Recent studies updated that TMJ arthroscopy promotes a reduction in pain and inflammatory process and restoring the mandibular function with low morbidity. Moreover, TMJ arthroscopy seems to be also long-term effective for relieving TMJ symptoms. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.
- Being tested
- bilateral temporomandibular joint arthroscopy, Xeomin® (Merz)
- Keywords
- Temporomandibular joint, TMJ arthroscopy, TMJ surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral temporomandibular joint arthroscopyProcedure or surgery
The TMJ arthroscopy was performed with a 1.9-mm arthroscope including a video system, with a 2.8-mm outer protective cannula. Briefly, for TMJ arthroscopy level 1, the authors used the classic puncture with an entry point 10 mm anterior and 2 mm below the Holmlund-Hellsing (H-H) line. A second puncture with a 21-G needle was performed 30 mm anterior and 7 mm below the H-H line to wash the joint with 250-300 ml Ringer solution. After washing the joint, 1.5-2 cc of hyaluronic acid was injected into it. For level 2 TMJ arthroscopy, the second puncture was substituted by a 2.8-mm outer protective cannula with a sharp trocar until the joint was reached. The 2.8-mm cannula was used for (1) intra-articular coblation and/or (2) intrasynovial medication. Antibiotic and non-steroidal anti-inflammatory drugs were routinely prescribed. Patients were instructed to follow a soft diet for 3 days after surgery and 5 physiotherapy and 3 speech therapy exercise sessions after intervention.
Xeomin® (Merz)Drug
For tenderness grade 2, 155U of Incobotulinum toxin A was injected in the masticatory muscles and for tenderness grade 3 195U of Incobotulinum toxin A was injected. The authors used Xeomin® (Merz) in all patients.
| Study group | Role | What they receive |
|---|---|---|
| bilateral temporomandibular joint arthroscopy | Experimental | Not described Receives: Procedure: bilateral temporomandibular joint arthroscopy; Drug: Xeomin® (Merz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Visual Analogue Scale (0,10)
VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
Measured: Pre-surgery
Pain (Visual Analogue Scale (0,10)
VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
Measured: Through study completion, an average of 2.5 years
Secondary outcomes (4)
Maximum mouth opening (MMO, mm)
Mouth opening measured with a ruler (mm)
Measured: Pre-surgery
Maximum mouth opening (MMO, mm)
Mouth opening measured with a ruler (mm)
Measured: Through study completion, an average of 2.5 years
Muscle tenderness (0-3 scale)
0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)
Measured: Pre-surgery
Muscle tenderness (0-3 scale)
0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)
Measured: Through study completion, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start2 Jan 2016
- Primary completion26 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Temporomandibular Joint DisorderStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective study
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues da Face
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Faustino Ângelo, Instituto Portugues da Face
- Investigators
- David Ângelo, MD, PhD, Principal investigator, Instituto Português da Face
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027243
- Sponsor's protocol ID
- TMJARTHRO
- Status last verified
- Sep 2021
- First submitted
- 24 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results
- ClinicalTrials.gov ID
- NCT05027243
- Acronym / sponsor ID
- TMJARTHRO
- Keywords
- Temporomandibular joint, TMJ arthroscopy, TMJ surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Instituto Portugues da FaceUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 30 Aug 2021 (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) arthroscopy has been used successfully for intra-articular disorders. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.
Detailed description
Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. It was first introduced by Onishi at 1975, as a pioneering technique to treat painful joints and has been associated with a reduction in the number of open joints surgeries. This minimally invasive technique allows observation of the TMJ upper compartment tissues, and sometimes the lower compartment. Moreover, this intervention allows joint lysis and lavage (level 1 arthroscopy) and intra-articular surgical procedures (level 2-3 arthroscopy).
Recent studies updated that TMJ arthroscopy promotes a reduction in pain and inflammatory process and restoring the mandibular function with low morbidity. Moreover, TMJ arthroscopy seems to be also long-term effective for relieving TMJ symptoms. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective study
| Arm | Type | Receives |
|---|---|---|
| bilateral temporomandibular joint arthroscopy | Experimental | Procedure: bilateral temporomandibular joint arthroscopy, Drug: Xeomin® (Merz) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age >16 years;
- clinical diagnosis of bilateral intra-articular disorder;
- clinical criteria for bilateral TMJ arthroscopy;
- magnetic resonance imaging (MRI) assessing the intra-articular derangement
Key exclusion criteria (2 listed)
- The exclusion criteria included any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks prior the study.
- Severe medical problems or mental illness, and pregnancy were also exclusion criteria
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 |
|---|---|---|
| bilateral temporomandibular joint arthroscopyThe TMJ arthroscopy was performed with a 1.9-mm arthroscope including a video system, with a 2.8-mm outer protective cannula. Briefly, for TMJ arthroscopy level 1, the authors used the classic puncture with an entry point 10 mm anterior and 2 mm below the Holmlund-Hellsing (H-H) line. A second puncture with a 21-G needle was performed 30 mm anterior and 7 mm below the H-H line to wash the joint with 250-300 ml Ringer solution. After washing the joint, 1.5-2 cc of hyaluronic acid was injected into it. For level 2 TMJ arthroscopy, the second puncture was substituted by a 2.8-mm outer protective cannula with a sharp trocar until the joint was reached. The 2.8-mm cannula was used for (1) intra-articular coblation and/or (2) intrasynovial medication. Antibiotic and non-steroidal anti-inflammatory drugs were routinely prescribed. Patients were instructed to follow a soft diet for 3 days after surgery and 5 physiotherapy and 3 speech therapy exercise sessions after intervention. | Procedure or surgery | bilateral temporomandibular joint arthroscopy |
| Xeomin® (Merz)For tenderness grade 2, 155U of Incobotulinum toxin A was injected in the masticatory muscles and for tenderness grade 3 195U of Incobotulinum toxin A was injected. The authors used Xeomin® (Merz) in all patients. | Drug | bilateral temporomandibular joint arthroscopy |
Primary outcome
Pain (Visual Analogue Scale (0,10)
Time frame: Pre-surgery
VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
Pain (Visual Analogue Scale (0,10)
Time frame: Through study completion, an average of 2.5 years
VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
4 secondary outcomes
Maximum mouth opening (MMO, mm)
Time frame: Pre-surgery
Maximum mouth opening (MMO, mm)
Time frame: Through study completion, an average of 2.5 years
Muscle tenderness (0-3 scale)
Time frame: Pre-surgery
Muscle tenderness (0-3 scale)
Time frame: Through study completion, an average of 2.5 years
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 16 Sep 2021.
- Individual participant dataSharing planned: No
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.
David Ângelo, MD, PhD principal investigator
Instituto Português da Face
Questions about this trial
What is this clinical trial studying?
A study testing bilateral temporomandibular joint arthroscopy and Xeomin® (Merz) in people with Bilateral Temporomandibular Joint Disorder, run by Instituto Portugues da Face.
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 2 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain (Visual Analogue Scale (0,10) (time frame: Pre-surgery). 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?
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 16 Sep 2021.