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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt)
Lidocaine (2% lidocaine hydrochloride, Pharco, Egypt)
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.
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGPain intensity assessed using the Visual Analogue Scale (VAS).
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.
Time frame: Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
Presence or absence of temporomandibular joint clicking sound assessed by clinical examination during mandibular movement.
Time frame: Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
Masseter muscle electrical activity assessed using surface electromyography (sEMG).
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.
Time frame: Preoperatively and 6 months postoperatively.
Maximum interocclusal opening measured in millimeters using a caliper.
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.
Time frame: Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
Range of lateral mandibular movement measured in millimeters using a caliper.
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.
Time frame: Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
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