Efficacy of Intra-Articular Hyaluronic Acid Combination Injections for Temporomandibular Joint Internal Derangement: A Clinical and MRI Based Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Joint Clicking
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Hyaluronic Acid + Tenoxicam
Participants receive a single intra-articular injection of hyaluronic acid combined with tenoxicam into the affected temporomandibular joint.
Intervention: intraarticular injection in TMJ (Procedure)
Hyaluronic Acid + Platelet-Rich Plasma (PRP)
Single intra-articular injection of hyaluronic acid combined with autologous platelet-rich plasma.
Intervention: intraarticular injection in TMJ (Procedure)
hyaluronic acid combined with corticosteroid.
Single intra-articular injection of hyaluronic acid combined with corticosteroid.
Intervention: intraarticular injection in TMJ (Procedure)
Outcomes
Primary Outcomes
Joint Clicking
Time Frame: Baseline, 1 week, 1 month, 3 months, and 6 months
Presence or absence of TMJ clicking will be recorded during mandibular movement.
MRI Evaluation
Time Frame: Baseline and 6 months
Magnetic resonance imaging will assess changes in disc position, joint morphology, and other structural characteristics following treatment.
Secondary Outcomes
No secondary outcomes reported