Therapeutic Effect of Proliferative Therapy (prolotherapy) on Pain Using Injectable Hypertonic Dextrose 25% Versus Injectable Dextrose 10% in Retrodiscal Tissues in Patients with Anterior Disc Displacement with Reduction: a Randomized Clinical Trial .

NCT06859034 | Not Yet Recruiting Phase 2

• 1 other identifier: prolotherapy injection in tmj
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

prolotherapy is an injection-based treatment method used to alleviate pain, particularly musculoskeletal pain associated with chronic ligament and tendon injuries. The process involves the injection of a solution, typically containing dextrose (a sugar), saline, or other irritants, into the affected tissues. Prolotherapy is believed to stimulate healing by causing a mild inflammatory response that promotes the regeneration of ligaments, tendons, and other connective tissues. This review explores the existing literature on the therapeutic effects of prolotherapy for pain management.

Conditions

TMJ Disc Disorder

Keywords

retrodiscal tissues

Outcome Measures

Primary Outcomes (1)

• Change in Pain Severity Measured by Numerical Rating Scale (NRS)

  Pain severity will be assessed using the Numerical Rating Scale (NRS) (0-10), where 0 = no pain and 10 = severe pain. Participants will report their pain levels at each time point. The mean change in NRS scores from baseline will be calculated and analyzed . Data Aggregation: Mean change in NRS score with standard deviation (SD)

  Measured at baseline, 1 month, 3 months, and 6 months after injections.

Secondary Outcomes (2)

• Change in Maximal Interincisal Opening (MIO) Measured in Millimeters

  Measured at baseline, 1 month, 3 months, and 6 months after injections

• Presence or Absence of Joint Clicking (Binary Outcome)

  Measured at baseline, 1 month, 3 months, and 6 months after injections

Study Arms (2)

injection of dextrose 10% in retrodiscal tissues

ACTIVE COMPARATOR

GROUP 1 will recieve 10% dextrose

Drug: injection of dextrose 10% in retrodiscal tissues

injection of dextrose 25% in retrodiscal tissues

EXPERIMENTAL

group 2 will recieve 25% dextrose

Drug: injection of dextrose 25% in retrodiscal tissues

Interventions

injection of dextrose 10% in retrodiscal tissues DRUG

group 1 will recieve 10% dextrose in retrodiscal tissues

injection of dextrose 10% in retrodiscal tissues

injection of dextrose 25% in retrodiscal tissues DRUG

group 2 will recieve 25% dextrose

injection of dextrose 25% in retrodiscal tissues

Eligibility Criteria

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

You may not qualify if:

• The clinical or radiographic signs of disc displacement without reduction .
• A history of allergic reactions to any components of the injectable solution.
• Blood dyscrasias and systemtic diseases .
• Previous surgery of the affected joint.
• Infection in pre-auricular area
• Patients should have one or more signs and symptoms of these
• Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
• Mouth Opening: Limited range of motion or difficulty with full mouth opening .
• Clicking: Audible clicking.
• Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• Haggag MA, Al-Belasy FA, Said Ahmed WM. Dextrose prolotherapy for pain and dysfunction of the TMJ reducible disc displacement: A randomized, double-blind clinical study. J Craniomaxillofac Surg. 2022 May;50(5):426-431. doi: 10.1016/j.jcms.2022.02.009. Epub 2022 Mar 8.

  PMID: 35501215 BACKGROUND

• Park JS, Ku JK, Kim YK, Yun PY. Efficacy of dextrose prolotherapy on temporomandibular disorder: a retrospective study. J Korean Assoc Oral Maxillofac Surg. 2024 Oct 31;50(5):259-264. doi: 10.5125/jkaoms.2024.50.5.259.

  PMID: 39482101 BACKGROUND

Study Officials

• nadia galal Professor, phd

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

nourhan moustafa nourhan moustafa abd el rahman hasan abo el ela, Bachelor's degree

CONTACT

01118233832; nourhan.hasan@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 5, 2025
• Study Start: March 3, 2025
• Primary Completion: September 3, 2025
• Study Completion: October 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03