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TMJ Disc DisorderTMJ_DistNCT03737305

RCT of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis

A study testing TMJ Condilar Distraction Device and Conventional Physical Therapy in people with TMJ Disc Disorder and TMJ Pain, run by Fonseca, Julio at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Articular Disc Displacements are the most common TMJ arthropathy and the articular distraction technique is one of the most common therapeutic resources. It is a technique almost exclusively performed by the physiotherapist and / or dentist, with repeated applications over an extended period of treatment, that can… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TMJ Condilar Distraction Device and Conventional Physical Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePortugal
Study dates
1 May 2018to 30 Jun 2019
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a minimum of 18 years of age
  • Diagnosis by the Research Diagnostic criteria of Temporomandibular Disorders (RDC / TMD), of disk displacement with or without reduction, with or without opening limitation (Group IIa, IIb or IIc) and atralgia (Group IIIa)
  • Clinical indication for the proposed treatment

Who cannot join

  • Patients <18 years
  • Pregnant patients
  • Absence of posterior teeth (not rehabilitated), advanced periodontal disease in the posterior teeth or patients with total dentures that compromise the use of the device
  • Diagnosis by the Research Diagnostic criteria of Temporomandibular Disorders (RDC / TMD), of Osteoarthritis (Group IIIb) and Osteoarthrosis (IIIc)
  • Presence of contralateral TMJ pathology, with no clinical indication for the proposed treatment, limiting the patient's mandibular mobility and influencing patient rehabilitation (eg, ankylosis or myofibrotic contracture)
  • History of surgery at the ATM
Show all 9Show fewer
  • Patients with systemic disease that may affect the TMJ
  • Aphasia, dementia, or known psychiatric or physical comorbidity that may interfere with communication or compliance during the rehabilitation process.
  • Patients blind, illiterate or with reduced cognitive abilities that may interfere with communication or compliance during the rehabilitation process.

Trial locations and contacts

1 site in 1 country.

Júlio Fonseca, Dr. contact

+351963628617

jfonsecas@hotmail.com

Júlio André Fonseca, Dr. contact

00351239826740

jfonsecas@hotmail.com

Portugal1 site, 1 recruiting
  • OrisClinic - Júlio Fonseca

    Coimbra, 3000-041

    Júlio Fonseca, 963628617, jfonsecas@hotmail.com

    Recruiting

Other trials in Portugal

About this study

Official title: Randomised Controlled Clinical Trial of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis

Articular Disc Displacements are the most common TMJ arthropathy and the articular distraction technique is one of the most common therapeutic resources. It is a technique almost exclusively performed by the physiotherapist and / or dentist, with repeated applications over an extended period of treatment, that can reach several weeks or months, difficult to perform manually by the patient on an ambulatory basis. Currently there are no ambulatory mandibular exercise devices that aim to execute articular distraction. Thus, the objective of this work was to study, design and develop a device capable of performing and / or assisting patients in the articular distraction maneuver.

Read the detailed description

Temporomandibular disorders are considered a heterogeneous group of psychophysiological disorders of the stomatognathic system (Okeson 1985, Okeson 1993) covering a broad spectrum of muscular, skeletal or both, clinical problems (Nagamatsu-Sakaguchi, Minakuchi et al). They are often initiated by pain, joint sounds and limited function / mandibular movement, and are considered one of the main causal factors of non-dental orofacial pain (Rossetti et al., 2008, Makino, Masaki et al.; Magnusson 1999). Conservative and non-invasive treatment is considered as the one of choice at an early stage, since the symptomatology is usually reduced through the combined use of occlusal appliences, physiotherapy and medication. (De Leeuw, American Academy of Orofacial Pain et al., 2008) The dislocations of the articular disc are the most common arthropathy and are characterized by several stages of clinical dysfunction involving an abnormal interrelationship of the disc condyle complex (more often an anterior or anteromedial disc displacement) (Isberg-Holm and Westesson 1982 ). Pain (in acute cases), changes in mandibular movement pattern and joint noise are the most frequent symptoms.

The causes of disc displacements are not completely established. It has been postulated that, in most cases, the elongation or rupture of the condyle-disc ligaments allows displacement of the disc. (Stegenga, de Bont et al., 1991) Changes in lubrication and synovial fluid quality have also been suggested as possible etiological agents (Nitzan 2001). The presence of osteoarthritis may also precipitate changes in the condyle-disc complex. (De Leeuw, American Academy of Orofacial Pain et al., 2008) In addition to the intervention of the dentist with occlusal appliance (among other resources), mandibular physiotherapy aims to reduce musculoskeletal pain, promote muscle relaxation, reduce muscle hyperactivity, improve muscle control and function, and maximize joint mobility . In addition to the electrotherapeutic means there are several manual therapy techniques directed to TMJ that aim the joint decompression, fibrosis reduction and adhesions at the level of structures such as ligaments or joint capsule, recaptation of the articular disc or adaptation of the retrodiscal tissues. We are talking about intraoral techniques such as condylar distraction or specific exercises of joint mobility or muscle strengthening. (Craane, Dijkstra et al., 2012) In the specific case of joint disc displacements, the condylar distraction technique is one of the most used therapeutic resources. It is a technique that aims to increase the space between the mandibular condyle and the joint fossa of the temporal, decompressing the joint and promoting the adaptation of the articular tissues and / or the disc reuptake. It is a technique almost exclusively performed by the physiotherapist and / or dentist, with repeated applications over an extended period of treatment that can reach several weeks or months, difficult to perform by the patient at home (De Leeuw, American Academy of Orofacial Pain et al, 2008). There are currently only ambulatory mandibular exercise devices that aim to increase the range of mandibular movement through rotation, rototranslation, and condylar translation (eg, TheraPace Jaw Motion Rehab System, TheraPacer Jaw CPM ). None of these devices distracts the joint, so in cases of acute displacement of the disc, with the presence of retrodiscal pain, they may even be counterproductive. Thus, the development of an apparatus capable of performing or assisting patients in the condylar distraction maneuver could prove to be a valuable aid in the treatment of these conditions, increasing patient adherence and reducing costs related to a long treatment time.

Being tested
TMJ Condilar Distraction Device, Conventional Physical Therapy
Keywords
TMJ, Disc Displacement, Temporomandibular Disorders, TMJ Distraction Device, TMJ Pain
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 Condilar Distraction DeviceDevice

    The patients will perform condylar distraction with the condylar distraction device in an ambulatory basis.

  • Conventional Physical TherapyDevice

    Conventional Physical Therapy, performed in office by a experienced physical therapist for the TMJ condition.

Study groups in NCT03737305
Study groupRoleWhat they receive
Control GroupActive comparatorControl group of conventional therapy with manual distraction performed by the physiotherapist in the office (active comparator)
Receives: Device: Conventional Physical Therapy
Distractor Test GroupExperimentalTest group with manual distraction performed by the physiotherapist in the office and the condylar distraction performed by the patient with the condylar distraction device in an ambulatory basis.
Receives: Device: TMJ Condilar Distraction Device

What is being measured

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

  1. Change of Pain at Rest (Visual Analogic Scale from 0-10)

    Mandibular Pain at Rest evaluated in a 0-10 (VAS) Visual Analogic Scale being 0 ´´No pain´´ and 10 ´´The worst pain ever´´

    Measured: 0 day, 7 days, 14 days, 28 days and 90 days of the study

  2. Change of Pain in Function (Visual Analogic Scale from 0-10)

    Mandibular Pain in Function evaluated in a 0-10 (VAS) Visual Analogic Scale being 0 ´´No pain´´ and 10 ´´The worst pain ever´´

    Measured: 0 day, 7 days, 14 days, 28 days and 90 days of the study

  3. Change of Subjective chewing efficiency

    Subjective chewing efficiency (evaluated in a 0-10 Visual Analogic Scale with 0 being ´´the worst efficiency ever´´ and 10 ´´the best efficiency ever´´)

    Measured: 0 day, 7 days, 14 days, 28 days and 90 days of the study

Secondary outcomes (2)
  1. Change in the Perceived subjective treatment effectiveness

    Perceived subjective treatment effectiveness on a five-point scale with 0 being ´´no perceived effectiveness´´ and 4 being the ´´maximum effectiveness´´

    Measured: 0 day, 7 days, 14 days, 28 days and 90 days of the study

  2. Change of Jaw range of motion function in millimetres

    Jaw range of motion function in millimetres (with no pain, with pain and maximum oppening)

    Measured: 0 day, 7 days, 14 days, 28 days and 90 days of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2018
  2. Study start1 May 2018
  3. Primary completion1 Jun 2019 (estimated)
  4. Study completion30 Jun 2019 (estimated)

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
Randomised
Intervention model
Parallel groups
Model description
This is a randomized controlled clinical trial, in a unique investigation center, non-blinded, parallel-group, comparative and interpretive study of the results of clinical use of a TMJ distraction device in patients with diagnosis of Articular Disorders, compared to the traditional method of treatment using manual physiotherapy.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03737305
Sponsor's protocol ID
TMJ_Distractor
Acronym
TMJ_Dist
Status last verified
Nov 2018
First submitted
3 Nov 2018
Last updated
13 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: All the results and further perspectives.

Questions about this trial

What is this clinical trial studying?

A study testing TMJ Condilar Distraction Device and Conventional Physical Therapy in people with TMJ Disc Disorder and TMJ Pain, run by Fonseca, Julio 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Nov 2018. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Júlio Fonseca, Dr. (+351963628617, jfonsecas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Pain at Rest (Visual Analogic Scale from 0-10) (time frame: 0 day, 7 days, 14 days, 28 days and 90 days of the study). The study lists 3 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 13 Nov 2018.

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