Faculty of Oral and Dental Medicine, Future University in Egypt
New Cairo, Cairo Governorate, 4740011, Egypt
NCT Number: NCT07630909
Temporomandibular joint disorders represent a complex and heterogeneous group of musculoskeletal conditions affecting the temporomandibular joint,masticatory muscles, and associated structures, frequently manifesting as chronic orofacial pain.
Temporomandibular joint (TMJ) disorders encompass a group of conditions affecting the jaw joint and associated musculature, leading to pain, impaired function, and a diminished quality of life. These disorders arise from various etiologies, including trauma,degenerative conditions such as osteoarthritis, and systemic inflammatory diseases, emphasizing their multifactorial nature.
Although the mechanism of action of mesotherapy in TMJ disorders involves delivering anti-inflammatory and analgesic agents directly to the affected area,the literature reveals a significant research gap regarding its efficacy and longterm benefits.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
New Cairo, Cairo Governorate, 4740011, Egypt
The temporomandibular joints (TMJs) are among the most frequently used joints in the body, opening and closing approximately 2,000 times a day. These joints are essential for various critical activities, including verbal and nonverbal communication, the challenging movements involved in chewing, and even the more subtle action of breathing. Healthy functioning of both the TMJs and the surrounding tissues is crucial for these activities. Additionally, the joints play a vital role in interpersonal interactions and contribute to facial expressions that convey emotions such as joy or sadness, as well as impacting self-esteem and self-identity.
Temporomandibular disorders are recognized as the most common chronic orofacial pain condition, with no significant differences found between racial groups. As previously defined, TMD refers to a group of pain conditions and dysfunctions, and not all epidemiological studies have used the same classification or differentiated between muscle and joint disorders. Indeed,inclusion criteria employed in studies before modern classifications encompassed some disorders into one entity.
This questions the validity of much of the epidemiologic research performed before criteria and diagnoses were standardized. This prevalence highlights the widespread impact of these conditions and underscores the critical need for effective diagnostic and therapeutic strategies.
The pathophysiology of TMJ disorders is complex, involving factors such as mechanical stress, inflammation, and genetic predisposition. These disorders typically affect the masticatory muscles, the TMJ itself, and the dentition,reflecting their multifaceted nature.
Management of TMJ disorders often requires a multidisciplinary approach,incorporating both conservative and invasive treatments tailored to the condition's severity and underlying causes.Among conservative treatments, mesotherapy has gained attention as a minimally invasive technique. This method involves intradermal or subcutaneous injections of pharmacological agents. The localized delivery allows for a timereleased therapeutic effect, minimizing systemic exposure.
The trigger points, the most sensitive points within a contracted muscle band,elicit pain upon compression and may be accompanied by referred pain. These points are considered active or latent based on their clinical characteristics.Active trigger points cause spontaneous pain and alter sensations in predictable pain patterns associated with that specific muscle. Latent trigger points, on the other hand, do not cause spontaneous pain but can restrict movement or cause muscle weakness. Myofascial pain is often misdiagnosed because the trigger point causing pain is often distant to where the pain is felt.
Mesotherapy has been used in managing various musculoskeletal conditions,including TMJ disorders, due to its potential to target underlying inflammatory processes. By modulating inflammation, mesotherapy may reduce pain and enhance joint functionality, aligning with the current focus on personalized, localized therapies. Some studies have reported positive outcomes, such as reduced pain and improved range of motion in patients with TMJ disorders.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mesotherapy involves the administration of very small doses of medications into the superficial layer of the skin over the painful muscle area. The injected solution typically contains lidocaine and anti-inflammatory agents. In this study, mesotherapy will be performed once weekly for four weeks using multiple superficial intradermal microinjections around the trigger points to reduce pain, improve local blood flow, and restore muscle function
Trigger point injection (TPI) consists of the direct intramuscular injection of a local anesthetic, such as lidocaine, hydrocortisone and ketolac into identified myofascial trigger points. The procedure aims to deactivate painful trigger points, relieve muscle spasm, and reduce referred pain. In this study, injections will be administered once weekly for four weeks using a standardized technique to ensure consistency and safety
Time frame: From 4 weeks to 3 months
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their pain before the first treatment and after completion of the 4-week treatment period.
Time frame: Baseline and 4 weeks after treatment initiation
Maximum mouth opening (MMO) will be measured as the distance between the incisal edges of the upper and lower central incisors using a calibrated digital caliper. Measurements will be taken at baseline and after completion of the 4-week treatment period. An increase in MMO indicates improved jaw function and reduction in myofascial pain-related muscle restriction. The mean change in MMO between the mesotherapy and trigger point injection groups will be compared
Time frame: Baseline, 4 weeks, and 3 months
Change in Quality of Life Measured by Oral Health Impact Profile (OHIP-14) Quality of life will be assessed using the Oral Health Impact Profile (OHIP-14) questionnaire.
The OHIP-14 consists of 14 items with scores ranging from 0 to 56, where higher scores indicate worse quality of life.
Assessments will be performed at baseline, after the 4-week treatment period, and at 3-month follow-up. Mean changes between groups will be compared.
Time frame: End of treatment (4 weeks) and 3-month follow-up
Patient satisfaction will be assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction.
Assessments will be performed at the end of the 4-week treatment period and at the 3-month follow-up.
Time
Future University in Egypt
Other
A Clinical Assessment of Mesotherapy as A Therapeutic Intervention for Myofascial Pain Syndrome: A Randomized Controlled Trial
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