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

NCT07401745 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-05

No results posted yet for this 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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Sarah A Elmaghraby, Lecturer · Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07401745 on ClinicalTrials.gov