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OpenTrials
Completed

NCT Number: NCT07020455

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with unilateral or bilateral TMJ hypermobility
  • history of open locking
  • complaints of joint sounds and facial pain
  • treated with combine or traditionally prolotherapy
  • followed for at least 3 months
  • the diagnosis of the patients was confirmed by TMJ radiography

Exclusion criteria

  • patients who underwent discectomy
  • patients with active infection (fever, redness, oedema, loss of function, etc.)
  • pathological findings (tumour, cyst, etc.) in the related area were excluded
  • patients with systemic disorders that could affect the results

Treatment and study plan

prolotherapy solution of 20% dextrose

Drug

Polotherapy, it involves injecting an irritant solution into weakened joints, ligaments, or tendons to stimulate collagen production and tissue repair at fibro-osseous junctions.

Arthrocentesis with ringer solution

Drug

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.

Primary outcomes

  1. Pain intensity of TMJ

    Time frame: From pre-treatment to the 3rd month after treatment

    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.

Secondary outcomes

  1. Maximal interincisal opening (MIO)

    Time frame: From pre-treatment to the 3rd month after treatment

    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).

Other outcomes

  1. TMJ sounds

    Time frame: From pre-treatment to the 3rd month after treatment

    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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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