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

Karadeniz Technical University

Status and phase: Completed; Phase 4

Conditions: Hypermobility Syndrome (Disorder); Prolotherapy; Temporomandibular Disorders (TMD); Hypermobility, Joint; Temporomandibular Pain; Arthrocentesis

Treatments: Drug: Arthrocentesis with ringer solution; Drug: prolotherapy solution of 20% dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT07020455

2025/6

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 17 to 46 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Combined Prolotherapy Group

Experimental group

Description:

Patients with TMJ hypermobility underwent arthrocentesis for joint pain in addition to prolotherapy.

Treatment:

Drug: prolotherapy solution of 20% dextrose

Drug: Arthrocentesis with ringer solution

Traditional Prolotherapy Group

Active Comparator group

Description:

Prolotherapy was applied to patients with TMJ hypermobility.

Treatment:

Drug: prolotherapy solution of 20% dextrose