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

NCT06839430 | Not Yet Recruiting

• 1 other identifier: injection in TMJ
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

TMJ Disc Displacement with Reduction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

painful cases with disc displacement with reduction

ACTIVE COMPARATOR

painful cases of disc displacement with reduction

EXPERIMENTAL

Other: hypertonic saline 5% sodium chloride

Interventions

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

painful cases of disc displacement with reduction

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

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• 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.

  PMID: 39115583 BACKGROUND

• 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.

  PMID: 37318462 BACKGROUND

• 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.

  PMID: 7214004 BACKGROUND

MeSH Terms

Interventions

Saline Solution, Hypertonic; Sodium Chloride

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

aya allah gamal salah, bachelors degree

CONTACT

+20 1005557843; ayaallah.gamal@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aya Allah Gamal

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share