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

Phase 4

Completed

• Conditions: Temporomandibular Disorders (TMD); Temporomandibular Pain; Hypermobility Syndrome (Disorder); Hypermobility, Joint; Arthrocentesis; Prolotherapy
• Interventions: Drug: prolotherapy solution of 20% dextrose; Drug: Arthrocentesis with ringer solution

• Registration Number: NCT07020455
• Lead Sponsor: Karadeniz Technical University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Prolotherapy Group	prolotherapy solution of 20% dextrose	Patients with TMJ hypermobility underwent arthrocentesis for joint pain in addition to prolotherapy.
Combined Prolotherapy Group	Arthrocentesis with ringer solution	Patients with TMJ hypermobility underwent arthrocentesis for joint pain in addition to prolotherapy.
Traditional Prolotherapy Group	prolotherapy solution of 20% dextrose	Prolotherapy was applied to patients with TMJ hypermobility.

Primary Outcome Measures

Name	Time	Method
Pain intensity of TMJ	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 Outcome Measures

Name	Time	Method
Maximal interincisal opening (MIO)	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).

Trial Locations

Locations (1)

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey