Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
NCT Number: NCT07750522
Temporomandibular joint (TMJ) disorders can cause jaw pain, clicking sounds, and difficulty opening the mouth, affecting daily activities such as eating and speaking. This study aims to determine whether magnetic resonance imaging (MRI) findings can help predict how much patients improve after a single injection into the TMJ containing hyaluronic acid and platelet-rich plasma (PRP).
Adults with TMJ internal derangement who have not improved with conservative treatment will receive one injection of hyaluronic acid combined with PRP prepared from their own blood. Participants will be evaluated before treatment and at follow-up visits over 6 months. Assessments will include pain, jaw function, mouth opening, and MRI scans before and after treatment.
The results of this study may improve understanding of the relationship between MRI findings and treatment outcomes and help healthcare providers identify patients who are most likely to benefit from this minimally invasive therapy.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, Egypt
Temporomandibular joint (TMJ) internal derangement is one of the most common temporomandibular disorders and is characterized by an abnormal relationship between the articular disc and the mandibular condyle, resulting in pain, joint sounds, and limitation of mandibular movement. Although clinical examination remains the primary diagnostic approach, magnetic resonance imaging (MRI) is considered the gold standard for evaluating TMJ soft tissue structures, including disc position, joint effusion, retrodiscal tissue, and inflammatory changes. However, MRI findings do not always correlate with symptom severity or treatment outcomes, making their prognostic value uncertain.
Intra-articular injection therapy has become a widely accepted minimally invasive treatment for TMJ internal derangement. Hyaluronic acid (HA) improves joint lubrication, reduces inflammation, and provides chondroprotective effects, whereas platelet-rich plasma (PRP) contains autologous growth factors that may enhance tissue repair and regeneration. The combination of HA and PRP may provide both symptomatic relief and biologic enhancement of joint healing.
This randomized controlled clinical trial aims to evaluate the relationship between MRI findings and clinical improvement following a single intra-articular injection of HA combined with PRP in patients with TMJ internal derangement with reduction. Sixty adult patients aged 18-45 years who have persistent symptoms despite conservative treatment and MRI-confirmed internal derangement with reduction will be enrolled.
Before treatment, all participants will undergo a comprehensive clinical examination, including assessment of pain intensity using the Visual Analog Scale (VAS), joint clicking, and maximum interincisal opening (MIO), as well as MRI evaluation of the affected TMJ. Platelet-rich plasma will be prepared from the participant's own blood and mixed with hyaluronic acid for intra-articular injection into the affected joint.
Clinical evaluations will be performed at baseline and at 1 week, 1 month, 3 months, and 6 months after treatment. MRI examinations will be repeated at 6 months. The primary objective is to determine whether baseline MRI findings correlate with and predict clinical improvement after treatment. Secondary objectives include evaluating changes in pain intensity, maximum mouth opening, and joint clicking following HA and PRP injection.
The findings of this study may improve understanding of the relationship between imaging findings and clinical outcomes and assist clinicians in selecting patients who are most likely to benefit from minimally invasive intra-articular injection therapy for TMJ internal derangement.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Platelet-rich plasma (PRP) will be prepared from 10 mL of the participant's peripheral venous blood using centrifugation. One milliliter of PRP will be mixed with 1 mL of hyaluronic acid and administered as a single intra-articular injection into the affected temporomandibular joint under aseptic conditions. Clinical outcomes (pain intensity, joint clicking, and maximum interincisal opening) will be evaluated at baseline and at 1 week, 1 month, 3 months, and 6 months after treatment. MRI examinations will be performed before treatment and at the 6-month follow-up to assess the relationship between MRI findings and clinical improvement.
Time frame: Baseline to 6 months
To determine whether baseline magnetic resonance imaging (MRI) findings correlate with and predict clinical improvement following a single intra-articular injection of hyaluronic acid combined with platelet-rich plasma. Clinical improvement will be assessed using pain intensity (Visual Analog Scale), maximum interincisal opening (MIO), and joint clicking. MRI will be repeated at 6 months to evaluate imaging changes.
Mansoura University
Other
Acronym: MRI TMJ
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