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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Portugal1 site
  • Instituto Português da Face

    Lisbon, 1050-227

Other trials in Portugal

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.

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 groups in NCT04857294
Study groupRoleWhat they receive
DiscectomyExperimentalUnilateral Discectomy
Receives: Procedure: TMJ unilateral discectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain (Visual Analogue Scale (0,10)

    VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

    Measured: Pre-surgery

  2. 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)
  1. Maximum mouth opening (MMO, mm)

    Mouth opening measured with a ruler (mm)

    Measured: Pre-surgery

  2. Maximum mouth opening (MMO, mm)

    Mouth opening measured with a ruler (mm)

    Measured: Through study completion, an average of 2 years

  3. 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

  4. 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.

  1. First posted23 Apr 2021
  2. Study start9 Jul 2015
  3. Primary completion11 Dec 2020
  4. Study completion31 Jan 2021

Resources

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)
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

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.

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