TMDPhase 4TMDNCT07401745
Occlusal Splint Combined With Granisetron Injection for Management of Myofascial Pain Related to Temporomandibular Disorders
A Phase 4 study testing Granisetron, lidocaine and occlusal splint in people with TMD and TMD/Orofacial Pain, run by Mansoura University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- TMD, TMD/Orofacial Pain, Temporomandibular Disorder (TMD)
- What is being tested?
- Granisetron, lidocaine and occlusal splint
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jan 2026to Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: 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:
Read more
- 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)
- Being tested
- Granisetron, lidocaine, occlusal splint
- Keywords
- TMD, temporomandibular disorder, orofacial pain, myofascial pain, granisetron, lidocaine, occlusal splint
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GranisetronDrug
Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt)
lidocaineDrug
Lidocaine (2% lidocaine hydrochloride, Pharco, Egypt)
occlusal splintDevice
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 group | Role | What they receive |
|---|---|---|
| Only occlusal splint group | Active comparator | This group will receive occlusal splint therapy only. Receives: 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. Receives: 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. Receives: Drug: lidocaine; Device: occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start27 Jan 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Elmaghraby, Mansoura University
- Investigators
- Sarah A Elmaghraby, Lecturer, Principal investigator, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401745
- Sponsor's protocol ID
- R.25.10.27
- Acronym
- TMD
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07401745
- Acronym / sponsor ID
- TMD / R.25.10.27
- Conditions
- TMD, TMD/Orofacial Pain, Temporomandibular Disorder (TMD)
- Keywords
- TMD, temporomandibular disorder, orofacial pain, myofascial pain, granisetron, lidocaine, occlusal splint
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Only occlusal splint group | Active comparator | Device: occlusal splintThis group will receive occlusal splint therapy only. |
| Occlusal splint and granisetron injection group | Experimental | Drug: Granisetron, Device: occlusal splintThis 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 | Drug: lidocaine, Device: occlusal splintThis 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. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GranisetronGranisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt) | Drug | Occlusal splint and granisetron injection group |
| lidocaineLidocaine (2% lidocaine hydrochloride, Pharco, Egypt) | Drug | Occlusal splint and lidocaine injection group |
| occlusal splintSpecially 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. | Device | Occlusal splint and granisetron injection group, Occlusal splint and lidocaine injection group, Only occlusal splint group |
Primary outcome
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.
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.
3 secondary outcomes
Masseter muscle electrical activity assessed using surface electromyography (sEMG).
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah A Elmaghraby, Lecturer principal investigator
Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Granisetron, lidocaine and occlusal splint in people with TMD and TMD/Orofacial Pain, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessed using the Visual Analogue Scale (VAS). (time frame: Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.