NCT07401745

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• TMD
• TMD/Orofacial Pain
• Temporomandibular Disorder (TMD)

Interventions

Type	Name	Description
DRUG	Granisetron	Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt)
DRUG	lidocaine	Lidocaine (2% lidocaine hydrochloride, Pharco, Egypt)
DEVICE	occlusal 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.

Timeline

• Start date: 2026-01-27
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-02-10
• Last updated: 2026-03-05

Locations

1 site across 1 country: Egypt