Temporomandibular Disorder (TMD), TMD, TMD/Orofacial Pain
Conditions
Keywords
TMD, temporomandibular disorder, orofacial pain, myofascial pain, granisetron, lidocaine, occlusal splint
Brief summary
The goal of this clinical trial is to evaluate whether a combination of occlusal splint therapy and granisetron injection into the masseter muscle is effective in managing myofascial pain related to temporomandibular disorders (TMD). The study will also compare this combination treatment to occlusal splint therapy alone and to occlusal splint therapy combined with lidocaine injection. The main questions this study aims to answer are: * Does adding granisetron injection to occlusal splint therapy reduce myofascial pain more effectively than occlusal splint therapy alone? * How does granisetron injection compare to lidocaine injection when combined with occlusal splint therapy? * Does the combination treatment improve mandibular movement and reduce joint clicking? * Are there any local or systemic side effects associated with granisetron or lidocaine injections? Researchers will compare three groups to evaluate treatment effectiveness: * Occlusal splint therapy alone * Occlusal splint therapy plus granisetron injection * Occlusal splint therapy plus lidocaine injection Participants will: * Wear an occlusal splint as part of their treatment * Attend follow-up visits after 1 week, 1 month, 3 months, and 6 months
Interventions
DRUGGranisetron
Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt)
DRUGlidocaine
Lidocaine (2% lidocaine hydrochloride, Pharco, Egypt)
DEVICEocclusal splint
Specially designed mouth guards that change the occlusal relationship of maxillary and mandibular teeth to improve the alignment of the tooth contact, with the aim of relieving temporomandibular pain.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Granisetron (Granitryl 1 mg/mL, ampules, EGYPHARMA, Egypt) will be used in group II, while lidocaine (2% lidocaine hydrochloride, Pharco, Egypt) will be used in group III. The most painful tender points to palpation of the masseter muscle will be marked, with a maximum of three per muscle. The injected volume into each tender point will be 0.5 mL. Thus, the maximum dose of granisetron a patient could receive will be 3 mg per treatment. As for lidocaine, the same amount as granisetron will be injected in the same way; the maximum injected amount will be below the maximum safe dosage (mg/kg) of lidocaine. The injections will be made perpendicular to the skin surface over the chosen tender point at an angle of 90°, using a 19-mm long needle (diameter 0.4 mm) attached to a 2-mL syringe. The solution will be administered into each tender point as a single shot over 10 seconds to ensure intramuscular administration. The injections will be repeated after 1 week in the most tender point.
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age: 19 - 45 years. * Diagnosis of myofascial pain according to the Research Diagnostic Criteria for TMD Axis I (RDC/TMD). * Pain upon digital palpation of the masseter and/or the temporalis muscles. * Patients with disc displacement with or without reduction in any of the TMJs. * Co-operative patients.
Exclusion criteria
* Diagnosed systemic muscular or joint diseases (e.g. fibromyalgia, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis). * Whiplash-associated disorder. * Neuropathic pain or neurological disorders (e.g. myasthenia gravis, orofacial dystonia). * History of psychiatric disorders. * Pain of dental origin. * Use of muscle relaxants or other medication that might influence the response to pain. * Pregnancy or lactation. * Known hypersensitivity to granisetron or lidocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity assessed using the Visual Analogue Scale (VAS). | Preoperatively and 1 week, 1month, 3 months and 6 months post operatively. | Pain intensity will be assessed using a Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain. Participants will mark their pain at rest and during jaw movements. |
| Presence or absence of temporomandibular joint clicking sound assessed by clinical examination during mandibular movement. | Preoperatively and 1 week, 1month, 3 months and 6 months post operatively. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Masseter muscle electrical activity assessed using surface electromyography (sEMG). | Preoperatively and 6 months postoperatively. | Electromyography will be acomplished using MyoWise (Myowise EMG/device, cometa srl manufacturing, Italy) device which is a surface electromyography (sEMG) system designed to record and analyze the electrical activity of muscles during rest and function. It utilizes adhesive surface electrodes to detect muscle action potentials, which are amplified, filtered, and displayed as real-time signals on a connected computer or tablet. The system provides quantitative data on muscle activation patterns, amplitude, and timing, allowing assessment of neuromuscular activity and coordination. |
| Maximum interocclusal opening measured in millimeters using a caliper. | Preoperatively and 1 week, 1month, 3 months and 6 months post operatively. | Maximum interocclusal opening will be measured in millimeters as the linear distance between the incisal edges of the maxillary and mandibular central incisors at maximum mouth opening. |
| Range of lateral mandibular movement measured in millimeters using a caliper. | Preoperatively and 1 week, 1month, 3 months and 6 months post operatively. | The range of lateral mandibular movement will be measured in millimeters as the horizontal displacement of the mandibular midline relative to the maxillary midline during maximum lateral excursion. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORSarah A Elmaghraby, Lecturer
Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
Outcome results
None listed