RCT of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis (NCT03737305) | Clinical Trial Compass
UnknownNot Applicable
RCT of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis
Portugal40 participantsStarted 2018-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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)
What they're measuring
1
Change of Pain at Rest (Visual Analogic Scale from 0-10)
Timeframe: 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)
Timeframe: 0 day, 7 days, 14 days, 28 days and 90 days of the study
3
Change of Subjective chewing efficiency
Timeframe: 0 day, 7 days, 14 days, 28 days and 90 days of the study
✕. 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.