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

Is The Combine Prolotherapy More Effective Than The Traditional Prolotherapy In Patients With Temporomandibular Joint Hypermobility?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07020455
Enrollment
26
Registered
2025-06-13
Start date
2019-01-01
Completion date
2025-01-01
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

hypermobility, subluxation, prolotherapy, arthrocentesis

Brief 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

Interventions

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.

Sponsors

Karadeniz Technical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

The first group applied prolotherapy, while the other group applied arthrocentesis and prolotherapy together.

Eligibility

Sex/Gender
ALL
Age
17 Years to 46 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity of TMJFrom pre-treatment to the 3rd month after treatmentPain 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

MeasureTime frameDescription
Maximal interincisal opening (MIO)From pre-treatment to the 3rd month after treatmentMaximal 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

MeasureTime frameDescription
TMJ soundsFrom pre-treatment to the 3rd month after treatmentTMJ 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026