Clinical Research Directory

Autologous Exosomes From Platelet-rich Plasma as a Modern Tool of Regenerative Dentistry

The aim of the research is the laboratory assessment of the content as well as the regenerative and anti-inflammatory potential of autologous exosomes (EXO) from platelet-rich plasma, as well as their comparison with other autologous products used in intra-articular injections (PRP, PRF). The material for the research will be obtained from patients of the Temporomandibular Joint Dysfunction Clinic at the University Dental Center in Wrocław with chronic pain of the temporomandibular joints and/or masticatory muscles and/or chronic disturbances in temporomandibular joint mobility, as well as from healthy individuals. In the subsequent stages, the biological material will be analyzed under laboratory conditions to compare the composition and biological properties of PRF, PRF and EXO.

Occlusal Splint and Exercise Therapy for Temporomandibular Disorders

The goal of this clinical trial is to learn if an exercise protocol can improve temporomandibular pain, jaw function and muscle mechanical properties in individuals with Temporomandibular Disorders (TMD). This study focuses on patients who are already receiving occlusal splint therapy. The main question it aims to answer is: How does the addition of an exercise protocol to occlusal splint therapy affect temporomandibular pain, jaw function and muscle mechanical properties of the masticatory and neck muscles? Researchers will compare the group receiving both occlusal splint therapy and the exercise protocol to a group only occlusal splint therapy to see if the combined approach is more effective. Participants will: * Undergo an initial assessment of the Jaw Functional Limitation Scale-20 (JLFS-20), Craniofacial Pain and Disability Inventory (CF-PDI), Graded Chronic Pain Scale Version 2.0 (GCPS-2.0), jaw range of motion, pain pressure threshold and muscle mechanical properties. * Receive occlusal splint therapy as a part of their treatment. * Perform a structured exercise protocol (only 1 group) * Attend follow up sessions at the 4th week to monitor changes in all initial assessment parameters.

INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR

Temporomandibular disorders (TMD) encompass all temporomandibular muscular and osteoarticular conditions. TMD affects 31% of the adult population, with chronic, debilitating pain in 10% of cases. Clinical diagnosis remains complex, and patients are underdiagnosed, whereas early management of these disorders can prevent worsening and significant public health expenditure. The Modjaw device, which is integrated into modern digital workflows in dental surgery-particularly for the manufacture of prostheses-could enable systematic joint diagnosis through the automatic interpretation of tracings. The validity of interpreting condylar tracings obtained via axiography (compared to MRI, considered the gold standard) for diagnosing disc displacement in the TMJ has been demonstrated. The team recently demonstrated the reproducibility of Modjaw® condylar recordings from healthy patients, as well as the reliability of the recordings. However, to date, the evaluation of this device has not focused on its added potential in terms of assisting the clinician in diagnosing disc displacement.

Comparing the Effectiveness of Online vs. Face-to-face Physiotherapy for Treating Temporomandibular Disorders

Dentists and physiotherapists have two options for treating these conditions: splint therapy and physiotherapy. Right now, the gold standard is individual physiotherapy, which contains manual therapy and active exercises too. Since not many dentists and physiotherapists are experts in this area, patients have to wait for months or even years to get their treatment. Thanks to social media, patients can find many information about their condition while they are waiting, but it's our responsibility to provide safe and effective information. In view of this situation, our aim is to find out if online or group physiotherapy is as effective as individual physiotherapy.

Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement

This study aims to rigorously assess the effectiveness of LPCGF in the management of internal disc displacement in patients with TMD through a randomized clinical trial. By comparing LPCGF therapy with conventional arthrocentesis, this research looks to provide robust evidence on the efficacy, safety, and potential role of (LPCGF) as an alternative therapeutic choice for IDD.

Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)

Chronic temporomandibular disorders (TMDs) affect the masticatory muscles, the temporomandibular joints (TMJs), and associated structures. Except in cases of trauma, their etiology remains uncertain, debated, and multifactorial. Conservative therapies-including no active intervention-often alleviate symptoms; however, approximately 3% of the population develops persistent forms associated with substantial individual suffering and significant social and economic burden. At the Unit of Occlusion and Prosthodontics of the University of Santiago de Compostela (USC), Physiologically Oriented Occlusal Equilibration (POOE) has been used for chronic painful TMDs since 1985. POOE aims to correct unilateral mastication patterns and to establish appropriate non-working side contacts in order to protect the temporomandibular joints from mechanical overload. Singh (Cochrane, 2024) emphasized that occlusal interventions should be evaluated with long-term follow-up of at least 3-5 years. This is a single-blind study: the evaluator remains blinded to treatment allocation during outcome assessment. The aim of this observational study is to assess the long-term effectiveness of POOE treatments for chronic TMDs from 1985 to the present. Treatment effectiveness will be confirmed if the reduction in pain achieved with POOE is statistically significant and clinically meaningful (≥1.5/10 on a 0-10 visual analog scale) compared with sham therapy at ≥3 years post-intervention relative to baseline. Additionally, effectiveness will be supported if the proportion of individuals meeting criteria for chronic TMD ("affected") is lower in the POOE-treated group than in those receiving alternative therapies.

Virtual Planning of Total Temporomandibular Joint Replacement

A total TMJ replacement surgery is currently planned based on the X-ray appearance of the facial X-ray. It is now possible to use either an individually designed TMJ prosthesis or a prosthesis with a standard appearance. It is a significantly higher cost for treatment with an individually manufactured prosthesis, but it also provides the opportunity for virtual planning of the positioning of the jaws and prosthesis. By using a planning program with treatment simulation through the use of our own virtual models for standard prostheses, virtual planning of jaw and prosthesis positioning is possible even with a standardized temporomandibular joint prosthesis. In this way, the advantages of virtual planning are partly brought to the patients at a much lower price. This project aims to virtually plan treatment for patients with standardized temporomandibular joint prosthesis. Patients eligible for this study are included retrospectively (have already been treated). Their X-rays will be used for treatment planning and for comparison with the treatment outcome of previous TMJ treatment. The study will analyze the possibilities of the standardized prostheses to provide the same positions, temporomandibular joint replacements and movements of the jaw as an individual temporomandibular joint prosthesis has. This is done by measuring the planned positions of standardized temporomandibular joint prostheses compared to the treatment outcome shown by previous postoperative X-ray examinations. The study aims to clarify the possibilities of a simpler and less expensive technology, standardized temporomandibular joint prostheses, to achieve the same good treatment outcome as a more costly technology. This with the same possibilities for treatment planning and use that the existing, more expensive technology, individual temporomandibular joint prostheses, has today.

Relationship Between Upper Cervical Mobility and Temporomandibular Joint Range of Motion in Patients With Temporomandibular Disorders

Upper cervical spine mobility plays a crucial role in temporomandibular joint (TMJ) function. This observational study investigates the relationship between upper cervical spine mobility and TMJ range of motion in patients diagnosed with temporomandibular disorders (TMD). Cervical hypomobility may restrict mandibular movement and contribute to TMJ dysfunction through shared biomechanical and neuromuscular mechanisms.

Journaling Intervention for Temporomandibular Disorder (TMD) and Chronic Overlapping Pain

The goal of this clinical trial is to learn whether a 2-week gratitude journaling activity is feasible and acceptable for individuals with Temporomandibular Disorder (TMD) and chronic overlapping pain. The study will also look at whether this activity is helpful in reducing pain and how much it interferes with daily life. The primary aims of this study are to: * Assess whether individuals with TMD and chronic overlapping pain are able to complete the 2-week gratitude journaling activity as planned (feasibility). * Evaluate how acceptable participants find the gratitude journaling activity (acceptability). The secondary aim of this study is to: • Explore whether the gratitude journaling activity reduces pain and its impact on daily life, compared to a general wellness journaling activity. Participants will: * Attend two in-person visits to complete questionnaires and take part in tests that measure how sensitive they are to pressure and heat. * Complete a 2-week journaling activity at home, writing in their journal on three days of their choice per week.

Effects of a Biopsychosocial Approach Added to Physiotherapy in Temporomandibular Disorders

Temporomandibular disorders are conditions that affect the jaw joint and surrounding muscles and may cause pain, limited jaw movement, stress, sleep problems, and teeth grinding. Physiotherapy is commonly used to manage these problems, but psychological and social factors may also influence symptoms. The purpose of this study is to examine whether adding a biopsychosocial approach to physiotherapy improves stress levels, sleep quality, and bruxism in individuals with temporomandibular disorders. Participants will receive either physiotherapy alone or physiotherapy combined with education about pain, stress management, and sleep habits. The results of this study may help improve treatment strategies for people with temporomandibular disorders.

Long-term Follow up of TMJ Surgery and Evaluation of the 6-month Control as a Prognostic Marker.

The goal of this clinical trial is to evaluate the long-term outcome of surgical intervention (arthroscopy or discectomy) due to the diagnoses temporomandibular joint disc displacement with or without displacement. The main questions it aims to answer are: * Does the surgical outcome recorded at the earlier 6-month follow up persist at the long-term follow up approximately 10 years postoperatively? * How does the radiologically determined degree of joint degeneration change with time in patients that have had joint surgery? Researchers will compare the six-month surgical outcome to the ten-year outcome to see if temporomandibular joint surgery results are stable over time. Participants with an earlier performed joint surgery will: * Have a clinical examination approximately ten years postoperatively. * Have a temporomandibular joint x-ray scan performed (cone-beam computed tomography).

Orofacial Pain Self-management: Personality Moderation Effect

The objective of this clinical trial is to study the effect of self-management on pain perception in patients with chronic orofacial pain and temporomandibular disorders (TMD) comparing it with the conventional treatment proposed by the TMD clinical practice guidelines. It also evaluates its effect on function and various psychosocial variables. As a secondary objective, this work proposes to study the variability between patients, in terms of personality factors, as moderators of the effect of treatment on pain perception. Including in the proposed statistical models certain covariates such as perception and/or coping with stress, anxiety and other psychosocial variables. This is a randomized clinical trial with two intervention groups and three measurement times (T0; pre-intervention, T1; post-5 weeks and T2; post-6 months). The experimental group will be applied a protocol based on self-management, which includes: therapeutic education, cognitive-behavioral tools, therapeutic exercise of the temporomandibular region, mind-body strategies and modifications of aspects related to lifestyle. The control group will carry out an intervention program based on the Clinical Practice Guidelines for the Management of Temporomandibular Joint Disorders. Therefore, using a set of tools based on therapeutic education, cognitive-behavioral tools for bruxism and other parafunctional habits, temporomandibular region exercises and manual therapy.

Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus

This clinical trial aims to investigate whether treatment of temporomandibular joint disorder with a stabilizing occlusal splint is justified to alleviate somatosensory tinnitus. The main questions we aim to answer are: * Determine if treatment of temporomandibular disorder with a stabilizing occlusal splint improves somatosensory tinnitus. * Identify which patient-related, tinnitus-related, and temporomandibular disorder-related factors contribute to the therapeutic effect.

Digitally Trained Applied Relaxation for Treatment of Temporomandibular Pain

Temporomandibular disorders (TMD) are common musculoskeletal pain conditions related to masticatory muscles and temporomandibular joints. Applied relaxation (AR) is a self-management method widely used and tested for treatment of various psychological and somatic conditions, including musculoskeletal pain and other chronic pain conditions. AR is trained step-by-step on a 6-week program under guidance of health care professional. For training of AR, a web application (Relappy) has been developed in University of Oulu, Finland. The aim of the project is to test the Relappy for training of AR. At first, Relappy is tested by volunteers (n=26). The randomized controlled trial on TMD patients evaluates the effectiveness of web application-based AR training on TMD pain symptoms, psychosocial burden, sleep quality and autonomic nervous system (ANS) activity. The study sample includes TMD patients (n=124) from Finnish Student Health Service in Oulu and Turku units. They are randomly assigned to 2 treatment groups: AR group (trained by AR web application) and stabilization splint group (traditional treatment). TMD pain, body pain, psychosocial symptoms and sleep problems are assessed with validated questionnaires at baseline and at 6-week, 3- month and 1-year follow-up points. The patients also use a digital sleep diary application. Additionally, ANS activity is measured from patients in Oulu before treatment and 3 months weeks and 1 year after baseline. In the analyses, the variables are compared between treatment groups. The present project also includes preparing of the commercialization, aiming to develop the Relappy for wider target groups of pain patients and public use, regardless of time and place of use. The project has many societal and economic impacts. It can be expected that when actively trained, web application for AR will offer a cost-efficient self-management method to relieve TMD pain, body pain, and other stress-related symptoms and thus improve general well-being. It is expected to reduce healthcare costs and treatment burden and promote sustainability.

The Effect of Non-Invasive Vagal Nerve Stimulation Combined With Self-Managed Therapy in Individuals With Myogenic Temporomandibular Dysfunction

The aim of our study is to determine the benefit of non-invasive Vagal Nerve Stimulation in combination with self-administered therapy on the symptoms associated with jaw joint dysfunction in individuals with jaw joint dysfunction. If you agree to participate in the study, you will fill out a form containing your information such as age, height, body weight. Then, Visual Analog Scale (VAS) and Central Sensitisation Scale will be used to assess the severity of jaw and neck joint pain. The 8-question Jaw Function Restriction Scale will be used to assess the limitation of jaw function. An algometer will be used to evaluate the pressure-pain threshold, and Therabite range of motion scale will be used to evaluate the range of motion of the jaw joint. One photograph will be taken from the side profile to evaluate the head-neck posture, this photograph will be used for craniocervical angle measurement and will not be shared elsewhere. Myotonmetry will be used to evaluate muscle mechanical properties and non-invasive superficial electromyography (yEMG) will be used to evaluate muscle activation. The treatments to be applied within the scope of the study will be carried out 3 days a week and the evaluation sessions will last 30 minutes.

TMJ Arthroscopy Compared to Arthrocentesis in Disc Displacement Without Reduction

The goal of this clinical trial is to compare the intervention arthroscopic lysis and lavage to the intervention arthrocentesis in treating disabling and painful temporomandibular joint disc displacement without reduction. The main questions it aims to answer are: * Which surgical method that best improves mouth opening capacity, TMJ pain, and TMJ disability? * If any pre- or peri-operative variable/-s could be identified as a predictor for surgical outcome? Researchers will compare arthroscopic lysis and lavage to arthrocentesis to see if arthroscopic lysis and lavage works better to treat temporomandibular joint disc displacement. Participants will: * Have one of the two interventions under general anesthesia, not knowing which intervention. * Visit an external clinic for regular checkups at 1, 3, 6, 12, and 24 months after surgery. * Answer three different quality of life surveys at the checkups.

TMJ Arthroscopic Lysis and Lavage Compared to Operative Arthroscopy in Disc Displacement With Reduction.

The goal of this clinical trial is to compare the intervention arthroscopic lysis and lavage to the intervention operative arthroscopy in treating disabling and painful temporomandibular joint disc displacement with reduction. The main questions it aims to answer are: * Which surgical method that best improves mouth opening capacity, TMJ pain, and TMJ disability? * If any pre- or peri-operative variable/-s could be identified as a predictor for surgical outcome? Researchers will compare arthroscopic lysis and lavage to operative arthroscopy to see if operative arthroscopy works better to treat temporomandibular joint disc displacement. Participants will: * Have one of the two interventions under general anesthesia, not knowing which intervention. * Visit an external clinic for regular checkups at 1, 3, 6, 12, and 24 months after surgery. * Answer three different quality of life surveys at the checkups.

Art-Based Pain Assessment Tool in Patients With Temporomandibular Joint Disorders

Title of Study: Assessment of the Impact of Art-Based Pain Assessment Tool on Pain Communication, Joint Function, and Anxiety in Patients with Temporomandibular Disorders (TMD): A Randomized Controlled Trial Location: King Abdulaziz University Dental Hospital (KAUFD), Jeddah, Saudi Arabia What Is This Study About? This study examines how an art-based tool can help improve communication and understanding of pain among patients with jaw joint disorders (TMD). It compares two groups: * Standard care: Routine diagnostic and therapeutic procedures * Intervention: Standard care plus a guided art-based tool using paintings to express and discuss the TMD experiences What Is the Art-Based Tool? This novel method, called the Artistic Pain Exploration (APE), uses paintings to help patients describe their pain that relates to TMD and its effect on their quality of life: 1. Participants will be shown three paintings (e.g., The Scream by Edvard Munch) 2. Participants will choose the one that best resonates with them 3. A guided discussion follows, exploring how the image relates to their physical and emotional pain as well as the effect of pain on their daily activities Research Questions: 1. Does using the APE method help participants better communicate and understand their pain? 2. Does it improve jaw function and reduce anxiety more than standard assessment? Who Can Participate? Participants may be eligible if they: * Are 18 years or older * Have early-stage TMD (not needing surgery) * Can give informed consent Participants cannot participate if they: * Require jaw surgery * Have severe mental illness (e.g., psychosis or bipolar disorder) * Take narcotic pain medications regularly What Will Happen During the Study? * Participants are randomly assigned to one of the two groups. * Each participant will complete a standardized questionnaire before and after two weeks to assess the level of anxiety. * All participants will be screened for depression via a standardized questionnaire before the first visit. * All will undergo a clinical exam to assess the TMJ pain and function and receive appropriate medications and lifestyle instructions. * Some participants (intervention group) will also discuss their pain using the artwork. * All participants will be seen for a follow up in 2 weeks to assess the TMJ function and pain. Potential Risks and Discomforts Participants may experience: * Emotional discomfort while discussing pain * Mild anxiety during interviews or questionnaires If needed, a psychiatrist on the research team will provide support or referrals. Potential Benefits * A better understanding of pain * Improved communication with care provider * Possible improvement in pain and jaw function Costs There are no costs to participate. All treatments are provided free of charge. Compensation / Treatment for Injury * If participants experience harm from this study, necessary medical care will be provided by the research team. * No financial compensation will be provided by King Abdulaziz University. Confidentiality Participants' identity and medical records will remain confidential. Only approved researchers and auditors will have access to data, in accordance with applicable laws. Any results published will not include participants' name or identifying details.

Behavioral Interventions for Controlling Oral Behaviors

Ecological momentary assessment (EMA) interventions via mobile devices can be implemented to monitor an individual's negative health behaviors in real-time, increase awareness, and assist patients in overting those behaviors. In recent years, EMA interventions have been used to improve patients' awareness of specific oral behaviors, such as tooth clenching or awake bruxism, which can produce excessive forces on the muscles of mastication and lead to or exacerbate symptoms of temporomandibular disorders (TMD). Yet, whether EMA interventions are effective in reducing oral behaviors and masticatory muscle activity in the short- and long-term, or whether they are more effective than patient education remains unclear. In this randomized clinical trial, we aim to test the effects of a 1-week EMA intervention combined with structured information on masticatory muscle activity and determine whether a combined approach including an EMA intervention and structured information is more effective in reducing masticatory muscle activity than structured information alone. Our study will have a significant impact on orofacial pain clinical research as it will provide clinically relevant measures which could inform multimodal approaches for the management of painful TMD.

ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

Emotional Release After Trigger Point Needling to Treat Myofascial Pain of the Head and Neck - Prospective Study

Temporomandibular Dysfunction (TMD) as classified by the DC-TMD has a significant psychosocial component referred to as "Axis II". One of the methods of treatment for myofascial TMD is "needing" which could be "dry needling" using only a needle or "wet needling" using local anesthetics. Practitioners of needling commonly observe an emotional release by the patient undergoing needling. This study aims to record and measure the emotional state of patients just before and just after needling for myofascial TMD via questionnaires.

Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders: A Randomized Sham-controlled Trial

The aim of the study was to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with temporomandibular disorders compared to sham control. Individuals diagnosed with temporomandibular disorder will be randomly assigned to groups as Group 1 (Manual Therapy Based on Fascial Distortion Model) and Group 2 (Sham Control). Head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization will be assessed.

Prevalence of Temporomandibular Joint Disorders in Wind Musicians

This study aims to analyze the prevalence of temporomandibular joint disorders (TMD) in wind musicians, differentiating the impact by instrument type (woodwind vs. brass) and identifying potential risk factors (embouchure, posture, practice time). A cross-sectional observational design will be used, including professional and student musicians from orchestras and conservatories.

The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals With Temporomandibular Disorders

The goal of this randomized clinical trial among US military active-duty service-members with temporomandibular disorders (TMD) is to determine whether standard care plus 6-weeks of tailored, individualized physical therapy (PT) treatment provides greater benefit than standard care alone in patient-reported outcomes, and maximal mouth opening. The aims of the study are to compare outcomes in individuals with TMD that receive standard care treatment versus standard care plus PT interventions at 0-, 6-, and 12-weeks. The investigators anticipate that subjects in the standard care plus PT group will exhibit improved patient-reported outcomes, and maximal mouth opening compared to those who received standard care alone. Additionally, the investigators will compare the amount and type of healthcare utilization between the two groups (Standard Care and Standard Care + PT) in the 12-month period following enrollment in the study. All participants will be managed by their primary dental provider and receive care as deemed appropriate by their provider. All participants will complete patient-reported outcome measures and have their jaw motion measured. Those randomized to the standard care plus PT group will also receive a tailored PT evaluation followed by an individualized plan of care two times per week for up to six weeks.