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

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: TMJ Disc Displacement with Reduction
• Intervention / Treatment: Other: hypertonic dextrose 20%; Other: hypertonic saline 5% sodium chloride

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: aya allah gamal salah, bachelors degree; Phone Number: +20 1005557843; Email: ayaallah.gamal@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• presence of one or more of the following observations in one or both temporomandibular joints:

  1. pain.
  2. audible clicking.
  3. mandibular deviation on opening.
  4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: painful cases with disc displacement with reduction	Other: hypertonic dextrose 20%; 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
Experimental: painful cases of disc displacement with reduction	Other: hypertonic saline 5% sodium chloride; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of pain	severity of pain is measured by Visual analog scale (VAS) From (0-10) Where 0: no pain 10: worst pain	baseline and at 6 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Gibaly A, Abdelmoiz M, Alghandour AN. Evaluation of the effect of dextrose prolotherapy versus deep dry needling therapy for the treatment of temporomandibular joint anterior disc displacement with reduction: (a randomized controlled trial). Clin Oral Investig. 2024 Aug 8;28(9):475. doi: 10.1007/s00784-024-05830-z.
• Mohammed MR, Hamad SA, Al-Dawoody AD, Shehab AA, Ahmed OS. Effect of dextrose prolotherapy on internal derangement of the temporomandibular joint. Eur Rev Med Pharmacol Sci. 2023 Jun;27(11):4883-4889. doi: 10.26355/eurrev_202306_32605.
• Zin'kovskii VG, Golovenko NIa, Bogatskii AV. [Nature of the relation between the anticonvulsant action of phenazepam and its concentration in mouse brain]. Biull Eksp Biol Med. 1981;91(1):40-2. Russian.

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 20, 2026

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: injection in TMJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No