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.
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
- Conditions the study is for
- TMJ Disc Disorder, TMJ Pain, TMJ Sounds on Opening/Closing the Jaw
- 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
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- 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.
Portugal1 site, 1 recruiting
- Recruiting
OrisClinic - Júlio Fonseca
Coimbra, 3000-041
Júlio Fonseca, 963628617, jfonsecas@hotmail.com
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.
- Conditions
- TMJ Disc Disorder, TMJ Pain, TMJ Sounds on Opening/Closing the Jaw, TMJ - Injury of Meniscus of Temporomandibular Joint
- 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 group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Control group of conventional therapy with manual distraction performed by the physiotherapist in the office (active comparator) Receives: Device: Conventional Physical Therapy |
| Distractor Test Group | Experimental | 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. Receives: Device: TMJ Condilar Distraction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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
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.
- First posted9 Nov 2018
- Study start1 May 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc 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
- 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)
Sponsor and investigators
- Lead sponsor
- Fonseca, Julio
- Responsible party
- Principal investigator, Júlio Fonseca, Fonseca, Julio
- Investigators
- Júlio Fonseca, Principal investigator, Dr.
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Clinical Trial of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis
- ClinicalTrials.gov ID
- NCT03737305
- Acronym / sponsor ID
- TMJ_Dist / TMJ_Distractor
- Conditions
- TMJ Disc Disorder, TMJ Pain, TMJ Sounds on Opening/Closing the Jaw, TMJ - Injury of Meniscus of Temporomandibular Joint
- Keywords
- TMJ, Disc Displacement, Temporomandibular Disorders, TMJ Distraction Device, TMJ Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fonseca, Julio
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 9 Nov 2018 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Conventional Physical TherapyControl group of conventional therapy with manual distraction performed by the physiotherapist in the office (active comparator) |
| Distractor Test Group | Experimental | Device: TMJ Condilar Distraction DeviceTest 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
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 Condilar Distraction DeviceThe patients will perform condylar distraction with the condylar distraction device in an ambulatory basis. | Device | Distractor Test Group |
| Conventional Physical TherapyConventional Physical Therapy, performed in office by a experienced physical therapist for the TMJ condition. | Device | Control Group |
Primary outcome
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´´
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´´
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´´)
2 secondary outcomes
Change in the Perceived subjective treatment effectiveness
Time frame: 0 day, 7 days, 14 days, 28 days and 90 days of the study
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Individual participant dataSharing planned: Undecided. All the results and further perspectives.
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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.
Júlio Fonseca principal investigator
Dr.
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 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.