TMJ Disc Disorder Clinical Trial
— TMJ_DistOfficial 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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Portugal | OrisClinic - Júlio Fonseca | Coimbra |
Lead Sponsor | Collaborator |
---|---|
Fonseca, Julio |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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´´ | 0 day, 7 days, 14 days, 28 days and 90 days of the study | |
Primary | 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´´ | 0 day, 7 days, 14 days, 28 days and 90 days of the study | |
Primary | 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´´) | 0 day, 7 days, 14 days, 28 days and 90 days of the study | |
Secondary | 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´´ | 0 day, 7 days, 14 days, 28 days and 90 days of the study | |
Secondary | Change of Jaw range of motion function in millimetres | Jaw range of motion function in millimetres (with no pain, with pain and maximum oppening) | 0 day, 7 days, 14 days, 28 days and 90 days of the study |
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