Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy

Temporomandibular Joint Disorders Clinical Trial

Official title:

Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy for the Treatment of Temporomandibular Joint Anterior Disc Displacement With Reduction (A Randomized Controlled Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05821985
• Other study ID #: 3
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypertonic dextrose injection; Prolotherapy is a proliferation injection therapy that aims to trigger a low-grade inflammatory response inside the (TMJ), with the resultant captivation of abundant fibroblasts that regenerate and strengthen the tendinous and ligamentous attachments and stabilize the disc and the fibro-osseous junctions. On the other hand, dry needling' refers to the insertion of needles without the use of injectate. Dry needling is beneficial for treating a variety of neuromusculoskeletal pain syndromes as it represents a treatment modality for the ligaments and tendons, muscles, subcutaneous fascia, peripheral nerves, and neurovascular bundles. Deep dry needling (DDN) is a technique that utilizes the Intracapsular insertion of dry needles to approach the discal insertion to the lateral pterygoid muscle and the masseteric muscle origin, along the zygomatic bone and arch, aiming to inactivate the muscular trigger points (TPs).

Description:

The Temporomandibular joint (TMJ) represents the most complex synovial articulation in the human body, with its articular disc enclosed between the articular tubercle's slope and the convexity of the mandibular condyle. Although the Magnetic resonance interpretation of the normal discal position defines the posterior discal band atop the highest convexity of the mandibular condyle, at a 12 o'clock position, this discal disposal is altered in almost 30% of the population without physical signs. Which rendered the treatment of the discal displacement mainly dependent on alleviating the signs and symptoms rather than restoring the anatomical disc position. Various non-invasive therapeutic modalities are utilized for relieving the signs and symptoms of anterior discal displacement, including physical therapy, exercises, ischemic compression, heat therapy, acupuncture, dry needling, wet needling injections with different agents, and pharmacological treatments. Among those, the trigger point injection is an effective modality, with or without the injection of saline or ringer's solutions, hyaluronic acid, corticosteroids, local anesthetics, botulinum toxin, platelet-rich plasma, or hypertonic dextrose The current study aims to design a randomized controlled trial that compares the effect of injecting 12.5 % of dextrose solution intraarticular and into the myofascial trigger points versus the dry needling of the same sites on alleviating the clinical signs and symptoms of (TMJ) disc displacement with reduction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Patients of both genders with an age group of 18-45 years.

2. Those patients with the radiographic interpretation of temporomandibular joint disc displacement with reduction (MRI) and the clinical signs of pain, limitation of mouth opening, and TMJ clicking.

3. The presence of associated myofascial pain with masseteric trigger points (TPs)

Exclusion Criteria:

1. Any previous temporomandibular joint treatment.

2. Any systemic disease affecting the temporomandibular joint's anatomy, mechanical function, or outcome of the proposed treatment.

3. Those Patients with a history of allergic reactions to any components of the injectable solution

Related Conditions & MeSH terms

• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• The study group
The patients within the study group will receive intraarticular TMJ and masseteric Trigger point injection of a solution that contains (0.75 ml. 12.5% Dextrose solution, 0.75 ml. Saline solution, and 1.5 ml. Lidocaine). Each patient will receive four injections at two-week intervals, aided by a 25 gauge needle connected to a 3 ml. plastic syringe.
• The Control group
The Control group: Patients in the control group will receive intraarticular TMJ and masseteric Trigger point dry needle insertion without injecting any solution. Each patient will receive four dry needle insertions at two-week intervals, aided by a 25-gauge and 3.8 cm length needle. i.e., All the patients will be subjected to intraarticular needle insertion. However, only the patients within the study group will be injected with the Dextrose Prolotherapy solution.

Locations

Country	Name	City	State
Egypt	Beni-suef university	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain threshold	by using visual analogue scale from 0 to 10 which 10 is the worst pain	8 months
Primary	Interincisal opening	distance by cm caliber from the between the anterior teeth at the maximal unassisted nonpainful opening of the patient.	8 months
Primary	clicking	(evident or not)	8 months