Clinical Research Directory

Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction

The aim of the study will be to analyze the results of injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. The treatment will consist in the administration of autologous blood products into the cavities of the temporomandibular joints.

Efficacy and Safety of HA35 Gel Nighttime Occlusive Application for TMD Pain

This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of nighttime occlusive application of 10% high-concentration 35 kDa hyaluronan (HA35) gel in subjects with temporomandibular joint disorder (TMD). Eligible participants will apply HA35 gel to the TMJ area nightly under occlusive conditions for 8-12 hours. The primary objectives are to assess rapid pain relief and muscle over-tension reduction at 60 seconds and 12 hours after application. Safety and local tolerability will be evaluated throughout the study period. This is a minimal-risk, non-pharmacological, non-invasive intervention.

Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

This study addresses the timely problem of painful temporomandibular disorders (TMD), the most common cause of orofacial pain second only to tooth pain. Findings from previous studies suggest that dysregulation of connectivity within specific brain circuits is part of chronic pain pathophysiology. This study will identify connectivity patterns within those brain circuits as potential signatures for pain- related disability in chronic TMD pain participants. New knowledge regarding these brain connectivity patterns is expected to be significant because it will support improved phenotyping of this heterogeneous participant population. It is also expected that this finding can potentially be extrapolated to other chronic pain conditions, such as back pain, migraine headache, and fibromyalgia that are frequently comorbid conditions in chronic TMD participants.

EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief

This prospective, multi-center, open-label, single-arm clinical study will evaluate the efficacy and performance of the BTL-043 and BTL-785F devices for alleviating TMJ pain. Up to 60 subjects will undergo four treatment visits, administered 2-10 days apart, followed by 1-month and 3-month follow-up visits. During a single treatment session at each visit, subjects will receive consecutive treatment with both devices. At baseline, informed consent, eligibility assessment, Fitzpatrick phototype evaluation, TMD Disability Index, VAS, weight and height measurements, 2D mandibular ROM photographs, and mandibular/lateral ROM assessments will be completed. A urine pregnancy test will be performed prior to each treatment visit. After the final treatment, subjects will complete the TCQ, SSQ \& QoL, TMD Disability Index, and VAS, and repeat all physical assessments. At both follow-up visits, subjects will complete the SSQ \& QoL, TMD Disability Index, and VAS, and repeat the physical assessments. Safety will be evaluated through documentation and assessment of adverse events at each treatment and follow-up visit.

Conservative Therapies in the Treatment of Temporomandibular Disorders

The present study was designed to evaluate different conservative therapies in patients with temporomandibular disorders. A total of 160 patients will be selected after the diagnosis of TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD), axis I. Patients will be randomly divided into five groups: OD group (n=32): treated with an occlusal device; LLLT group (n=32): treated with infrared low-level laser; ODL group (n=32): treated with OD + LLLT; LAT group (n=32): treated with laser acupuncture and ODLAT group (n=32): treated with both OD and LAT. Patients undergoing therapy with a stabilizing plate (made using the simplified technique) will be instructed to use the device every night while sleeping for four weeks. In both the LLLT and LAT groups, the protocol involved five applications: one at baseline, followed by four subsequent weekly sessions. The intensity of pain will be classified using the Visual Analog Scale (VAS). Mandible function will be assessed by maximum unassisted mouth opening. The impact of therapies on oral health will also be evaluated using the Oral Health Impact Profile (OHIP-14) instrument in a simplified form.