NCT07020455 — drugset

Summary

1. Diagnosis and Indication You have been diagnosed with temporomandibular joint (TMJ) hypermobility and/or dysfunction, characterized by symptoms such as jaw clicking, locking, pain in the joint area, or difficulty in opening and closing the mouth. After clinical and radiographic evaluation, the recommended treatment includes arthrocentesis and prolotherapy, either alone or in combination. 2. Description of Procedures A. TMJ Arthrocentesis: This is a minimally invasive procedure in which small needles are inserted into the TMJ space to irrigate the joint using sterile fluid (e.g., Ringer's solution). The procedure aims to eliminate inflammatory mediators, release joint adhesions, and improve mandibular mobility. It is generally performed under local anesthesia in an outpatient setting. B. Prolotherapy: Prolotherapy involves the injection of an irritant solution (typically dextrose combined with a local anesthetic) into the joint capsule, ligaments, or surrounding tissue. The goal is to stimulate the body's natural healing response, promoting collagen production and tissue regeneration to improve joint stability and function. C. Combined Approach: In certain cases, both treatments may be performed during the same session to maximize clinical benefit-arthrocentesis addresses inflammation and mobility, while prolotherapy enhances long-term stabilization. 3. Benefits and Expected Outcomes Reduction in TMJ pain and joint clicking Improved jaw function and range of motion Stabilization of the joint and reduced recurrence of dislocation or subluxation Minimally invasive and generally well-tolerated 4. Possible Risks and Complications Although these procedures are generally safe, potential risks may include but are not limited to: Mild pain or swelling at the injection site Temporary facial numbness or weakness (rare and usually self-resolving) Dizziness or light-headedness Joint stiffness or infection (very rare) Allergic reaction to anesthetic or injected substances 5. Alternatives to the Proposed Procedure You have the right to consider other treatment options, which may include: Physical therapy or jaw exercises Oral splints or bite guards Medication (analgesics, muscle relaxants) Surgical interventions (if conservative methods fail) 6. Patient Instructions and Post-Procedure Care Avoid wide mouth opening, yawning, or chewing hard foods for several days Use only recommended medications (e.g., acetaminophen/paracetamol); avoid anti-inflammatory drugs unless advised otherwise Apply cold compresses to reduce swelling if necessary Attend all scheduled follow-up appointments Notify your doctor immediately if you experience severe pain, prolonged numbness, fever, or signs of infection

Timeline

Start: 2019-01-01
Primary completion: 2022-01-01
Completion: 2025-01-01

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dextrose	Unknown	20 %	Other

Is the Combine Prolotherapy More Effective Than the Traditional Prolotherapy in Patients With Temporomandibular Joint Hypermobility?

Summary

Timeline

Publications

Drugs

Indications