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Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy

Primary Purpose

Temporomandibular Joint Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
The study group
The Control group
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Beni-suef university

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

The Study group

The Control group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Pain threshold
by using visual analogue scale from 0 to 10 which 10 is the worst pain
Interincisal opening
distance by cm caliber from the between the anterior teeth at the maximal unassisted nonpainful opening of the patient.
clicking
(evident or not)

Secondary Outcome Measures

Full Information

First Posted
March 29, 2023
Last Updated
April 18, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05821985
Brief Title
Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy
Official Title
Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy for the Treatment of Temporomandibular Joint Anterior Disc Displacement With Reduction (A Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
The Temporomandibular joint (TMJ) represents the most complex synovial articulation in the human body, with its articular disc enclosed between the articular tubercle's slope and the convexity of the mandibular condyle. Although the Magnetic resonance interpretation of the normal discal position defines the posterior discal band atop the highest convexity of the mandibular condyle, at a 12 o'clock position, this discal disposal is altered in almost 30% of the population without physical signs. Which rendered the treatment of the discal displacement mainly dependent on alleviating the signs and symptoms rather than restoring the anatomical disc position. Various non-invasive therapeutic modalities are utilized for relieving the signs and symptoms of anterior discal displacement, including physical therapy, exercises, ischemic compression, heat therapy, acupuncture, dry needling, wet needling injections with different agents, and pharmacological treatments. Among those, the trigger point injection is an effective modality, with or without the injection of saline or ringer's solutions, hyaluronic acid, corticosteroids, local anesthetics, botulinum toxin, platelet-rich plasma, or hypertonic dextrose The current study aims to design a randomized controlled trial that compares the effect of injecting 12.5 % of dextrose solution intraarticular and into the myofascial trigger points versus the dry needling of the same sites on alleviating the clinical signs and symptoms of (TMJ) disc displacement with reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The Study group
Arm Type
Other
Arm Description
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).
Arm Title
The Control group
Arm Type
Other
Arm Description
Patients in the control group will receive intraarticular TMJ and masseteric Trigger point dry needle insertion without injecting any solution.
Intervention Type
Procedure
Intervention Name(s)
The study group
Intervention Description
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 three injections at two-week intervals, aided by a 25 gauge needle connected to a 3 ml. plastic syringe.
Intervention Type
Procedure
Intervention Name(s)
The Control group
Intervention Description
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 three 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.
Primary Outcome Measure Information:
Title
Pain threshold
Description
by using visual analogue scale from 0 to 10 which 10 is the worst pain
Time Frame
6 months
Title
Interincisal opening
Description
distance by cm caliber from the between the anterior teeth at the maximal unassisted nonpainful opening of the patient.
Time Frame
6 months
Title
clicking
Description
(evident or not)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beni-suef university
Phone
0822324879082
Email
info@bsu.edu.eg
Facility Information:
Facility Name
Beni-suef university
City
Banī Suwayf
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy

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