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

NCT07401745 | Active Not Recruiting Phase 4

• 1 other identifier: R.25.10.27
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

TMD; temporomandibular disorder; orofacial pain; myofascial pain; granisetron; lidocaine; occlusal splint

Outcome Measures

Primary Outcomes (2)

• Pain intensity assessed using the Visual Analogue Scale (VAS).

  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.

  Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.

Secondary Outcomes (3)

• Masseter muscle electrical activity assessed using surface electromyography (sEMG).

  Preoperatively and 6 months postoperatively.

• Maximum interocclusal opening measured in millimeters using a caliper.

  Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.

• Range of lateral mandibular movement measured in millimeters using a caliper.

  Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.

Study Arms (3)

Only occlusal splint group

ACTIVE COMPARATOR

This group will receive occlusal splint therapy only.

Device: occlusal splint

Occlusal splint and granisetron injection group

EXPERIMENTAL

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.

Drug: Granisetron; Device: occlusal splint

Occlusal splint and lidocaine injection group

EXPERIMENTAL

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.

Drug: lidocaine; Device: occlusal splint

Interventions

Granisetron DRUG

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

Occlusal splint and granisetron injection group

lidocaine DRUG

Lidocaine (2% lidocaine hydrochloride, Pharco, Egypt)

Occlusal splint and lidocaine injection group

occlusal splint DEVICE

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.

Occlusal splint and granisetron injection group; Occlusal splint and lidocaine injection group; Only occlusal splint group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Interventions

Granisetron; Lidocaine; Occlusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Sarah A Elmaghraby, Lecturer

  Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Model Details: Granisetron (Granitryl 1 mg/mL, ampules, EGYPHARMA, Egypt) will be used in group II, while lidocaine (2% lidocaine hydrochloride, Pharco, Egypt) will be used in group III. The most painful tender points to palpation of the masseter muscle will be marked, with a maximum of three per muscle. The injected volume into each tender point will be 0.5 mL. Thus, the maximum dose of granisetron a patient could receive will be 3 mg per treatment. As for lidocaine, the same amount as granisetron will be injected in the same way; the maximum injected amount will be below the maximum safe dosage (mg/kg) of lidocaine. The injections will be made perpendicular to the skin surface over the chosen tender point at an angle of 90°, using a 19-mm long needle (diameter 0.4 mm) attached to a 2-mL syringe. The solution will be administered into each tender point as a single shot over 10 seconds to ensure intramuscular administration. The injections will be repeated after 1 week in the most tender point.

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)