Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy

NCT05821985 | Completed

• 1 other identifier: 3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (3)

• Pain threshold

  by using visual analogue scale from 0 to 10 which 10 is the worst pain

  8 months

• Interincisal opening

  distance by cm caliber from the between the anterior teeth at the maximal unassisted nonpainful opening of the patient.

  8 months

• clicking

  (evident or not)

  8 months

Study Arms (2)

The Study group

OTHER

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).

Procedure: The study group

The Control group

OTHER

Patients in the control group will receive intraarticular TMJ and masseteric Trigger point dry needle insertion without injecting any solution.

Procedure: The Control group

Interventions

The study group PROCEDURE

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 Study group

The Control group PROCEDURE

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.

The Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both genders with an age group of 18-45 years.
• 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.
• The presence of associated myofascial pain with masseteric trigger points (TPs)

You may not qualify if:

• Any previous temporomandibular joint treatment.
• Any systemic disease affecting the temporomandibular joint's anatomy, mechanical function, or outcome of the proposed treatment.
• Those Patients with a history of allergic reactions to any components of the injectable solution

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university

Banī Suwayf, Egypt

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 20, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)