A Phase 4 interventional study of prolotherapy solution of 20% dextrose and Arthrocentesis with ringer solution in Temporomandibular Disorders (TMD), Temporomandibular Pain and Hypermobility Syndrome (Disorder), sponsored by Karadeniz Technical University. Completed at 1 site in Turkey. Open to participants aged 17 Years to 46 Years. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Karadeniz Technical University · Phase 4, Interventional, and Treatment
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.
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
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
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)
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
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's enrollment of 26 is below the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Karadeniz Technical University is the lead sponsor of 153 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Patients with TMJ hypermobility underwent arthrocentesis for joint pain in addition to prolotherapy.
Drug: prolotherapy solution of 20% dextrose · Drug: Arthrocentesis with ringer solution
Prolotherapy was applied to patients with TMJ hypermobility.
Drug: prolotherapy solution of 20% dextrose
Polotherapy, it involves injecting an irritant solution into weakened joints, ligaments, or tendons to stimulate collagen production and tissue repair at fibro-osseous junctions.
Integrating arthrocentesis with prolotherapy may enhance therapeutic outcomes by addressing both the mechanical and inflammatory aspects of TMJ hypermobility. This dual-modality technique presents a promising minimally invasive option for clinicians managing patients with joint instability.
Pain intensity of TMJ
Pain intensity of TMJ evaluated by visual analog scale (VAS) questionnaire. VAS is designated by an marked horizontal line, 10 mm long, scored from 0 (no pain) to 10 (intolerable pain), anchored by word identifiers at each end. Patients marked the point on the line that they thought represented their current situation.
Time frame: From pre-treatment to the 3rd month after treatment
Maximal interincisal opening (MIO)
Maximal interincisal opening (MIO) was recorded by measuring the distance between the incisal edges of the upper and lower incisors in the midline with the help of a ruler. Maximal interincisal opening was measured preoperatively (T0), postoperatively 1 week (T1), 1 month (T2) and 3 months (T3).
Time frame: From pre-treatment to the 3rd month after treatment
TMJ sounds
TMJ sounds were evaluated as click or no click during mouth opening. The presence of clicking sound and pain were evaluated preoperatively and 3 months. The other variables studied were demographic data (gender and age) and the affected side.
Time frame: From pre-treatment to the 3rd month after treatment
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 2019-2022
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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