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

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ClinicalTrials.gov Identifier: NCT03737305
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Júlio Fonseca, Fonseca, Julio

Brief 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 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.

Condition or disease Intervention/treatment Phase
TMJ Disc Disorder TMJ Pain TMJ Sounds on Opening/Closing the Jaw TMJ - Injury of Meniscus of Temporomandibular Joint Device: TMJ Condilar Distraction Device Device: Conventional Physical Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: The Outcomes Assessor, or secondary investigator does nor have the knowlegde of the group of patients that is being evaluated.
Primary Purpose: Treatment
Official Title: Randomised Controlled Clinical Trial of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 30, 2019

Arm Intervention/treatment
Active Comparator: Control Group
Control group of conventional therapy with manual distraction performed by the physiotherapist in the office (active comparator)
Device: Conventional Physical Therapy
Conventional Physical Therapy, performed in office by a experienced physical therapist for the TMJ condition.

Experimental: Distractor Test Group
Test 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.
Device: TMJ Condilar Distraction Device
The patients will perform condylar distraction with the condylar distraction device in an ambulatory basis.




Primary Outcome Measures :
  1. 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 ]
    Mandibular Pain at Rest evaluated in a 0-10 (VAS) Visual Analogic Scale being 0 ´´No pain´´ and 10 ´´The worst pain ever´´

  2. Change of Pain in Function (Visual Analogic Scale from 0-10) [ Time Frame: 0 day, 7 days, 14 days, 28 days and 90 days of the study ]
    Mandibular Pain in Function evaluated in a 0-10 (VAS) Visual Analogic Scale being 0 ´´No pain´´ and 10 ´´The worst pain ever´´

  3. Change of Subjective chewing efficiency [ Time Frame: 0 day, 7 days, 14 days, 28 days and 90 days of the study ]
    Subjective chewing efficiency (evaluated in a 0-10 Visual Analogic Scale with 0 being ´´the worst efficiency ever´´ and 10 ´´the best efficiency ever´´)


Secondary Outcome Measures :
  1. Change in the Perceived subjective treatment effectiveness [ Time Frame: 0 day, 7 days, 14 days, 28 days and 90 days of the study ]
    Perceived subjective treatment effectiveness on a five-point scale with 0 being ´´no perceived effectiveness´´ and 4 being the ´´maximum effectiveness´´

  2. Change of Jaw range of motion function in millimetres [ Time Frame: 0 day, 7 days, 14 days, 28 days and 90 days of the study ]
    Jaw range of motion function in millimetres (with no pain, with pain and maximum oppening)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a minimum of 18 years of age
  2. 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)
  3. Clinical indication for the proposed treatment

Exclusion Criteria:

  1. Patients <18 years
  2. Pregnant patients
  3. 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
  4. Diagnosis by the Research Diagnostic criteria of Temporomandibular Disorders (RDC / TMD), of Osteoarthritis (Group IIIb) and Osteoarthrosis (IIIc)
  5. 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)
  6. History of surgery at the ATM
  7. Patients with systemic disease that may affect the TMJ
  8. Aphasia, dementia, or known psychiatric or physical comorbidity that may interfere with communication or compliance during the rehabilitation process.
  9. Patients blind, illiterate or with reduced cognitive abilities that may interfere with communication or compliance during the rehabilitation process.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737305


Contacts
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Contact: Júlio Fonseca, Dr. +351963628617 jfonsecas@hotmail.com
Contact: Júlio André Fonseca, Dr. 00351239826740 jfonsecas@hotmail.com

Locations
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Portugal
OrisClinic - Júlio Fonseca Recruiting
Coimbra, Portugal, 3000-041
Contact: Júlio Fonseca    963628617    jfonsecas@hotmail.com   
Sponsors and Collaborators
Fonseca, Julio
Investigators
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Principal Investigator: Júlio Fonseca Dr.

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Responsible Party: Júlio Fonseca, Doctor (Dentistry); Principal Investigator, Fonseca, Julio
ClinicalTrials.gov Identifier: NCT03737305     History of Changes
Other Study ID Numbers: TMJ_Distractor
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All the results and further perspectives.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Júlio Fonseca, Fonseca, Julio:
TMJ
Disc Displacement
Temporomandibular Disorders
TMJ Distraction Device
TMJ Pain
Additional relevant MeSH terms:
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Disease
Pathologic Processes