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

March 3, 2026 updated by: Sarah Elmaghraby, Mansoura University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35511
        • Faculty of Dentistry, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Only occlusal splint group
This group will receive occlusal splint therapy only.
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.
Experimental: Occlusal splint and granisetron injection group
This group will receive occlusal splint therapy in addition to multiple injection of granisetron that will be administered via intramuscular injection at a dose of 0.5 mL.
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.
Drug: Granisetron
Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt)
Experimental: Occlusal splint and lidocaine injection group
This group will receive occlusal splint therapy in addition to multiple injection of lidocaine that will be administered via intramuscular injection at a dose of 0.5 mL.
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.
Drug: lidocaine
Lidocaine (2% lidocaine hydrochloride, Pharco, Egypt)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
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.
Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperatively and 6 months postoperatively.
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.
Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
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.
Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Sarah A Elmaghraby, Lecturer, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.25.10.27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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