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NCT Number: NCT06839430

Therapeutic Effect of Using Injectable Hypertonic Saline 5% Versus Injectable Dextrose 20% on Pain in Painful Cases of Disc Displacement With Reduction

This study is aiming to assess effect of hypertonic saline 5% in comparison to dextrose 20% on pain ,inter-insical opening and movements of jaw in painful cases of disc displacement with reduction

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Key information

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Intra-articular disorders of the TMJ have been defined as an abnormal positional relationship between the disc and the condyle, articular eminence, and/or articular fossa.

The term internal derangement of the temporomandibular joint (TMJ) indicates an abnormal relationship between the disc, the condyle, and the articular eminence that constrains proper joint function

The disc displacement could be with or without reduction. In disc displacement with reduction, the disc is displaced anterior to the condylar head and remains in this position as long as the mouth is closed. Upon mouth opening, the disc regains its position on the condylar head. The movement of the disc onto and off the condylar head may lead to a clicking sound .

The precise source of internal derangements is not clear; however, it is a complex disorder likely caused by a combination of micro- or macro-trauma, parafunctional behavior, laxity of the joint's soft tissues, and alterations in the synovial fluid's composition

The aims of the internal derangement treatment include alleviating pain, reducing or eliminating joint noises, increasing the degree of mouth opening, and consequently restoring normal TMJ function.

Soft diet, behavior adjustment, analgesics, occlusal splints, intra-articular injections, physiotherapy, arthrocentesis, arthroscopy, and open joint surgery are the most common therapeutic techniques Injecting a non pharmacological irritant solution ,such as dextrose, into the area of the tendons or ligaments is known as prolotherapy, which is also known as regenerative injection therapy. It is hypothesized that this procedure elicits a non inflammatory or inflammatory process that ultimately leads to the deposition of new collagen fibers that strengthen lax tendons or ligaments and possibly encourage the release of local growth factor Different substances have been utilized for prolotherapy, but hypertonic dextrose is the most commonly utilized solution since it is affordable, accessible, and safe to inject Dextrose solution has been used at various concentrations ranging from 10% to 50% The superior joint space and peri-capsular soft tissues are usually injected during traditional prolotherapy of the TMJ.

Injection treatment of TMJs is currently one of the recognized therapeutic techniques.

Due to its invasive nature, only patients who have exhausted the less invasive treatment options are typically eligible for injection treatment.

Depending on the injectable substance used, injection treatment provides pain relief and increases the range of mandibular mobility Hypertonic saline , administered via intra-articular injection has been widely used in many previous clinical trials ,it has been used in patients with knee osteoarthritis and show significant improvement regarding pain, stiffness and function of joint hypertonic saline has a significant pain relief effect ,it acts as an analgesic by alleviating nociceptive pain from inflamed tissues, which may include bone, connective tissue, synovium, or a combination of these

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • presence of one or more of the following observations in one or both temporomandibular joints:
  • pain.
  • audible clicking.
  • mandibular deviation on opening.
  • Failure of conservative treatment

Exclusion criteria

  • The clinical or radiographic signs of disc displacement without reduction, osteoarthritis, or articular bony changes.
  • Previous TMJ surgery, arthrocentesis, , or the presence of any systemic disease that would affect the TMJ anatomy or mechanical function.
  • A history of allergic reactions to any components of the injectable solution.
  • Infection of the affected joint and pre-auricular area.
  • Previous surgery of the affected joint

Treatment and study plan

hypertonic saline 5% sodium chloride

Other

Hypertonic saline acts as an analgesic by alleviating nociceptive pain from inflamed tissues, which may include bone, connective tissue , synovium , or a combination of these Hypertonic saline results in safe and remarkable outcomes on knee pain, stiffness and function compared with intra-articular dextrose injection

hypertonic dextrose 20%

Other

A recent study showed the sensorineural analgesic effect of 5% dextrose prolotherapy in the treatment of chronic low back pain ,Therefore, the mechanism of action for dextrose prolotherapy is hypothesized to work through reducing peripheral sensitization and targeting structural dysfunction

Primary outcomes

  1. Severity of pain

    Time frame: baseline and at 6 months

    severity of pain is measured by Visual analog scale (VAS) From (0-10) Where 0: no pain 10: worst pain

Study contacts

Contact information is provided by the study sponsor or research team.

aya allah gamal salah, bachelors degree

CONTACT

[email protected]

+20 1005557843

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Therapeutic Effect of Using Injectable Hypertonic Saline 5% Versus Injectable Dextrose 20% on Pain in Painful Cases of Disc Displacement With Reduction ( A Randomized Clinical Trial)

Acronym: RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2025
Registry last updated
Mar 7, 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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