Temporomandibular DisordersNCT04857294
Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation
A study testing TMJ unilateral discectomy in people with Temporomandibular Disorders, run by Instituto Portugues da Face at 1 site in Portugal.
Trial summary
Temporomandibular joint (TMJ) discectomy is one of the most popular surgical techniques for painful TMJ. Previous studies have demonstrated predictable results of discectomy with optimal results in pain reduction and maximum mouth opening (MMO) improvement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- TMJ unilateral discectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 sitePortugal
- Study dates
- 9 Jul 2015to 31 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years old;
- Unilateral TMJ pain >7 (0-10 VAS) and/or MMO < 30mm;
- MRI presenting unilateral disc perforation or disc fragmentation
- Clinical and imaging examination with criteria for unilateral TMJ discectomy
Who cannot join
- Previous TMJ surgical intervention;
- Concomitant contralateral surgery;
- Age < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Temporomandibular joint (TMJ) discectomy is one of the most popular surgical techniques for painful TMJ. Previous studies have demonstrated predictable results of discectomy with optimal results in pain reduction and maximum mouth opening (MMO) improvement. However, those studies had most of the times varied inclusion criteria. A 4-year prospective study was designed including patients treated with unilateral TMJ discectomy without interposal material as the first surgical procedure for two specific intra-articular diagnosis: disc perforation and disc fragmentation.
Read the detailed description
Temporomandibular disorders (TMD) are the most prevalent orofacial pain source of nondental origin. Those disorders can be due to a heterogeneous group of pathologies affecting the temporomandibular joint (TMJ), the jaw muscles, or both. TMD symptoms prevalence has been reported between 10 to 33% of the population. The most common symptoms include pain, joint sounds, limitation of mandibular movement, facial deformities, condyle dislocation and recurrent headaches. These symptoms can negatively affect the quality of life. Surgical treatments for TMD are reserved for specific cases, however with the popularization of mini-invasive surgical techniques such as TMJ arthroscopy, more patients have been eligible for these mini-invasive techniques, amplifying the scope of TMJ surgery. In diagnostics such as ankylosis, tumors and growth abnormalities, TMJ open surgery is strongly recommended. However, those diagnosis and relatively uncommon. TMJ internal derangement involving disc position/integrity and osteoarthrosis are more frequent, but the surgical indication is relative.
From all the open surgery techniques, TMJ discectomy without interposal material is probably one of the most popular procedures. Recently, was showed that bilateral discectomy can induce severe TMJ changes detected with both imaging and histopathologic analysis in black Merino sheep. Besides, the critical histological and imaging results, functional masticatory alterations were not influenced by TMJ degenerative changes. Also, in other preclinical study, disc and fibrocartilage removal lead to traumatic TMJ ankylosis. It is interesting to observe the role of the condyle and temporal fibrocartilage, balancing the disc function. In humans, short-term studies on TMJ discectomy were associated with good results. In fact, in other retrospective study was showed discectomy without replacement is effective improving the preoperative maximum mouth opening (MMO). Despite the good clinical outcome, some studies have observed degenerative changes in imaging analysis. Together, clinical and preclinical results showed TMJ discectomy is a suboptimal technique, and an effective disc substitute, acting as a cushion between the condyle and temporal fossa could, in theory, improve these results. Despite extensive research in the field of tissue engineering, currently no appropriate disc substitute has demonstrated safety and efficacy. In fact, the last guidelines do not recommend disc replacement because nonvalid option showed superiority over discectomy alone. While there is no effective disc substitute, discectomy is often used when the disc is partial or total damaged and cannot be salvaged and/or and when symptoms fail to improve with other techniques. The inclusion criteria heterogeneity in previous studies, retrospective studies and non-randomization makes it difficult to draw clear conclusions about this technique. The investigators designed a rigorous prospective study for patients with: 1) unilateral TMJ disc perforation or 2) unilateral TMJ disc fragmentation. Those patients were proposed to unilateral TMJ discectomy. Most of the times, when the disc is damaged, the bone fibrocartilage is distorted and the authors wanted to understand the role of discectomy is those patients.
- Conditions
- Temporomandibular Disorders
- Being tested
- TMJ unilateral discectomy
- Keywords
- Temporomandibular, TMJ Discectomy, TMJ Meniscectomy, TMJ Surgery
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMJ unilateral discectomyProcedure or surgery
All patients underwent general anesthesia with nasotracheal intubation, managed in most cases with intravenous anesthesia protocol, usually with remifentanil infusion. Intraoperative steroids, usually dexamethasone, were administered primarily to minimize postoperative swelling. A classic preauricular incision or a root of helix inter tragus notch incision (RHITNI) was used in most cases, as previously described. No bandage or special care was performed after the surgery. No air washing restrictions were recommended.
| Study group | Role | What they receive |
|---|---|---|
| Discectomy | Experimental | Unilateral Discectomy Receives: Procedure: TMJ unilateral discectomy |
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 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 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 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start9 Jul 2015
- Primary completion11 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues da Face
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Ângelo, MD, PhD, Study director, Instituto Português da Face
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857294
- Sponsor's protocol ID
- TMJDISCECT
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 23 Apr 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 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation
- ClinicalTrials.gov ID
- NCT04857294
- Acronym / sponsor ID
- TMJDISCECT
- Conditions
- Temporomandibular Disorders
- Keywords
- Temporomandibular, TMJ Discectomy, TMJ Meniscectomy, TMJ Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Instituto Portugues da FaceUniversity, hospital or other
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 23 Apr 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) discectomy is one of the most popular surgical techniques for painful TMJ. Previous studies have demonstrated predictable results of discectomy with optimal results in pain reduction and maximum mouth opening (MMO) improvement. However, those studies had most of the times varied inclusion criteria. A 4-year prospective study was designed including patients treated with unilateral TMJ discectomy without interposal material as the first surgical procedure for two specific intra-articular diagnosis: disc perforation and disc fragmentation.
Detailed description
Temporomandibular disorders (TMD) are the most prevalent orofacial pain source of nondental origin. Those disorders can be due to a heterogeneous group of pathologies affecting the temporomandibular joint (TMJ), the jaw muscles, or both. TMD symptoms prevalence has been reported between 10 to 33% of the population. The most common symptoms include pain, joint sounds, limitation of mandibular movement, facial deformities, condyle dislocation and recurrent headaches. These symptoms can negatively affect the quality of life. Surgical treatments for TMD are reserved for specific cases, however with the popularization of mini-invasive surgical techniques such as TMJ arthroscopy, more patients have been eligible for these mini-invasive techniques, amplifying the scope of TMJ surgery. In diagnostics such as ankylosis, tumors and growth abnormalities, TMJ open surgery is strongly recommended. However, those diagnosis and relatively uncommon. TMJ internal derangement involving disc position/integrity and osteoarthrosis are more frequent, but the surgical indication is relative.
From all the open surgery techniques, TMJ discectomy without interposal material is probably one of the most popular procedures. Recently, was showed that bilateral discectomy can induce severe TMJ changes detected with both imaging and histopathologic analysis in black Merino sheep. Besides, the critical histological and imaging results, functional masticatory alterations were not influenced by TMJ degenerative changes. Also, in other preclinical study, disc and fibrocartilage removal lead to traumatic TMJ ankylosis. It is interesting to observe the role of the condyle and temporal fibrocartilage, balancing the disc function. In humans, short-term studies on TMJ discectomy were associated with good results. In fact, in other retrospective study was showed discectomy without replacement is effective improving the preoperative maximum mouth opening (MMO). Despite the good clinical outcome, some studies have observed degenerative changes in imaging analysis. Together, clinical and preclinical results showed TMJ discectomy is a suboptimal technique, and an effective disc substitute, acting as a cushion between the condyle and temporal fossa could, in theory, improve these results. Despite extensive research in the field of tissue engineering, currently no appropriate disc substitute has demonstrated safety and efficacy. In fact, the last guidelines do not recommend disc replacement because nonvalid option showed superiority over discectomy alone. While there is no effective disc substitute, discectomy is often used when the disc is partial or total damaged and cannot be salvaged and/or and when symptoms fail to improve with other techniques. The inclusion criteria heterogeneity in previous studies, retrospective studies and non-randomization makes it difficult to draw clear conclusions about this technique. The investigators designed a rigorous prospective study for patients with: 1) unilateral TMJ disc perforation or 2) unilateral TMJ disc fragmentation. Those patients were proposed to unilateral TMJ discectomy. Most of the times, when the disc is damaged, the bone fibrocartilage is distorted and the authors wanted to understand the role of discectomy is those patients.
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 |
|---|---|---|
| Discectomy | Experimental | Procedure: TMJ unilateral discectomyUnilateral Discectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old;
- Unilateral TMJ pain >7 (0-10 VAS) and/or MMO < 30mm;
- MRI presenting unilateral disc perforation or disc fragmentation
- Clinical and imaging examination with criteria for unilateral TMJ discectomy
Key exclusion criteria (3 listed)
- Previous TMJ surgical intervention;
- Concomitant contralateral surgery;
- Age < 18 years old
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 |
|---|---|---|
| TMJ unilateral discectomyAll patients underwent general anesthesia with nasotracheal intubation, managed in most cases with intravenous anesthesia protocol, usually with remifentanil infusion. Intraoperative steroids, usually dexamethasone, were administered primarily to minimize postoperative swelling. A classic preauricular incision or a root of helix inter tragus notch incision (RHITNI) was used in most cases, as previously described. No bandage or special care was performed after the surgery. No air washing restrictions were recommended. | Procedure or surgery | Discectomy |
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 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 years
Muscle tenderness (0-3 scale)
Time frame: Pre-surgery
Muscle tenderness (0-3 scale)
Time frame: Through study completion, an average of 2 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 23 Apr 2021.
- Individual participant dataSharing planned: No
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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.
David Ângelo, MD, PhD study director
Instituto Português da Face
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMJ unilateral discectomy in people with Temporomandibular Disorders, run by Instituto Portugues da Face at 1 site in Portugal.
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 23 Apr 2021. 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 Portugal. 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?
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 23 Apr 2021.