Temporomandibular Joint Internal Derangement
Conditions
Brief summary
This randomized controlled clinical trial aims to compare the clinical and magnetic resonance imaging (MRI) outcomes of three intra-articular injection protocols for the treatment of temporomandibular joint (TMJ) internal derangement with reduction. Sixty patients who remain symptomatic despite conservative therapy will be randomly assigned to receive hyaluronic acid combined with platelet-rich plasma (PRP), tenoxicam, or corticosteroid. Clinical outcomes including pain intensity, maximum mouth opening, and joint clicking, together with MRI findings, will be evaluated over a 6-month follow-up period.
Detailed description
Temporomandibular joint (TMJ) internal derangement is a common disorder associated with pain, joint sounds, and limitation of mandibular function. Although conservative treatment is considered the first-line therapy, some patients continue to experience persistent symptoms requiring minimally invasive intervention. Hyaluronic acid (HA) is widely used for intra-articular injection because of its lubricating and anti-inflammatory properties. Platelet-rich plasma (PRP) has demonstrated regenerative potential through the release of growth factors that may promote tissue healing. Corticosteroids provide potent anti-inflammatory effects but may adversely affect cartilage with repeated use, whereas tenoxicam is a long-acting nonsteroidal anti-inflammatory drug with favorable analgesic and anti-inflammatory properties. This prospective randomized controlled clinical trial will compare three treatment protocols: Hyaluronic acid combined with tenoxicam Hyaluronic acid combined with platelet-rich plasma Hyaluronic acid combined with corticosteroid Sixty patients diagnosed with TMJ internal derangement with reduction confirmed by MRI and unresponsive to conservative treatment will be randomly allocated in a 1:1:1 ratio to one of the three intervention groups. Clinical assessments will include pain intensity using the Visual Analog Scale (VAS), maximum mouth opening (MMO), and joint clicking at baseline, 1 week, 1 month, 3 months, and 6 months. MRI examinations will be performed at baseline and 6 months to evaluate structural changes within the joint
Interventions
PROCEDUREintraarticular injection in TMJ
Hyaluronic Acid + Tenoxicam: Single intra-articular injection of hyaluronic acid combined with tenoxicam administered to the affected temporomandibular joint. Platelet-Rich Plasma + Hyaluronic Acid: Single intra-articular injection of autologous platelet-rich plasma combined with hyaluronic acid administered to the affected temporomandibular joint. Hyaluronic Acid + Corticosteroid: Single intra-articular injection of hyaluronic acid combined with corticosteroid administered to the affected temporomandibular joint.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to one of three parallel treatment groups in a 1:1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 45 years. TMJ internal derangement with reduction confirmed by MRI. Early or intermediate disease according to Wilkes classification. Painful TMJ with clicking, with or without limited mouth opening. Persistent symptoms despite conservative treatment. Able and willing to provide informed consent and attend follow-up visits.
Exclusion criteria
* nflammatory or connective tissue disorders. Previous TMJ surgery. Neurological disorders. Previous TMJ injection within the last 6 months. Fibrous or bony ankylosis/adhesion. Internal derangement without reduction. Psychological disorders affecting study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Joint Clicking | Baseline, 1 week, 1 month, 3 months, and 6 months | Presence or absence of TMJ clicking will be recorded during mandibular movement. |
| MRI Evaluation | Baseline and 6 months | Magnetic resonance imaging will assess changes in disc position, joint morphology, and other structural characteristics following treatment. |
Countries
Egypt
Outcome results
None listed