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

Study acronym: TMD
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 5, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  2. Notable Primary endpoints revised (2) Eligibility criteria revised · Secondary endpoints revised (3) · Study title expanded, about 1 wordv2 Show 3 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints revised (3)
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07401745
Lead Sponsor Mansoura University
Conditions TMD, TMD/Orofacial Pain, Temporomandibular Disorder (TMD)
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov