Occlusal Splint Combined With Granisetron Injection for Management of Myofascial Pain Related to Temporomandibular Disorders

NCT07401745 — Phase 4, Active not recruiting, 48 participants, Mansoura University

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Combination Treatment of Occlusal Splint Appliance and Granisetron Injection Into the Masseter Muscle for Management of Myofascial Pain Related to Temporomandibular Disorders: A Randomized Controlled Parallel-arm Clinical Trial

Registry	NCT07401745, acronym TMD
Status	Active not recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	48 (Actual)
Sponsor	Mansoura University (Other)
Conditions	TMD, TMD/Orofacial Pain, Temporomandibular Disorder (TMD)
Interventions	Granisetron, lidocaine, occlusal splint (Drug, device)
Dates	start 2026-01-27, primary completion 2026-07-01 (estimated), completion 2026-07-01 (estimated), first posted 2026-02-10, last updated 2026-03-05
Locations	1 site in Egypt

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Only occlusal splint group	Active comparator	Device: occlusal splint	This group will receive occlusal splint therapy only.
Occlusal splint and granisetron injection group	Experimental	Drug: Granisetron; Device: occlusal splint	This group will receive occlusal splint therapy in addition to multiple injection of granisetron that will be administered via intramuscular injection at a dose of 0.5 mL.
Occlusal splint and lidocaine injection group	Experimental	Drug: lidocaine; Device: occlusal splint	This group will receive occlusal splint therapy in addition to multiple injection of lidocaine that will be administered via intramuscular injection at a dose of 0.5 mL.

Granisetron (Drug): Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt)
lidocaine (Drug): Lidocaine (2% lidocaine hydrochloride, Pharco, Egypt)
occlusal splint (Device): 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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 19 Years to 45 Years

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

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry, Mansoura University	Al Mansurah, Dakahlia Governorate	Egypt

+Investigators

Sarah A Elmaghraby, Lecturer, Principal investigator, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.