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

Condition(s) studied

Investigational drug(s) / intervention(s)

Granisetron: Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt)

lidocaine: Lidocaine (2% lidocaine hydrochloride, Pharco, Egypt)

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.

Study 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

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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