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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:
Researchers will compare three groups to evaluate treatment effectiveness:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only occlusal splint group | Active Comparator | This group will receive occlusal splint therapy only. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granisetron | Drug | Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Masseter muscle electrical activity assessed using surface electromyography (sEMG). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah A Elmaghraby, Lecturer | Faculty of Dentistry, Mansoura University, Mansoura, Egypt. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Mansoura University | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
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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.
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| lidocaine | Drug | Lidocaine (2% lidocaine hydrochloride, Pharco, Egypt) |
|
| 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. |
|
| Preoperatively and 6 months postoperatively. |
| Maximum interocclusal opening measured in millimeters using a caliper. | 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. | 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. |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017829 | Granisetron |
| D008012 | Lidocaine |
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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