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NCT Number: NCT07401745

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

TMD Craniomandibular Disorders Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases TMD/Orofacial Pain Temporomandibular Disorder (TMD) Temporomandibular Joint Disorders

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain intensity assessed using the Visual Analogue Scale (VAS).

    Time frame: 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.

  2. 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.

Secondary outcomes

  1. Masseter muscle electrical activity assessed using surface electromyography (sEMG).

    Time frame: 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.

  2. Maximum interocclusal opening measured in millimeters using a caliper.

    Time frame: 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.

  3. Range of lateral mandibular movement measured in millimeters using a caliper.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: TMD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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