Mandibular SplintNCT06553950
Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
A study testing Botox injection, Mandibular stabilization splint and Muscle relaxant in people with Mandibular Splint and Botox, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to compere mandibular splint versus botox injection in lateral pterygoid on cervical muscle activity in patients with temporomandibular disorders Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mandibular Splint, Botox, Lateral Pterygoid
- What is being tested?
- Botox injection, Mandibular stabilization splint and Muscle relaxant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Aug 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18-40 years old.
- Both sexes.
- Duration of the disease is more than 3 months.
- Anterior mandibular disc displacement with reduction will be included.
- Unilateral anterior mandibular displacement with reduction grade 2\&3 (Wilkes) will be included.
- Patients with cervical muscles spasm and trigger points (upper trapezius\& sternocleidomastoid) will be included.
- Patients with sufficient cognitive abilities that enables them to understand and follow instructions.
Who cannot join
- Neurological or musculoskeletal diseases that affect cervical spine other than mandibular disc displacement (eg: cervical spondylosis, spondylolisthesis, and cervical disc injuries)
- Bilateral anterior mandibular disc displacement patients.
- Musculoskeletal disorders such as severe arthritis, cervical spine surgery or contractures of fixed deformity, leg length discrepancy.
- women during pregnancy and lactation.
- Patients with known hypersensitivity to any component of the drug (especially hypersensitivity to human albumin).
- Patients with infection or inflammation of the area where the toxin injections are planned, in patients with musculoskeletal conduction disorders, in primary muscular disorders (muscular dystrophy, neuromyopathy, congenital myopathies, myotonic disorders, mitochondrial myopathy and unspecified or other primary muscle disorders).
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- Patients being treated with aminoglycoside antibiotics, ciclosporin, D-penicillamine, tubocurarine, pancuronium, gallamine, succinylcholine, chloroquine, or hydroxychloroquine.
- History of cervical spine surgery.
- History of trauma or fractures in cervical spine.
- Signs of cervical radiculopathy or myelopathy.
- Vascular syndrome such as vertebrobasilar insufficiency.
- Signs of serious pathology ( e.g., malignancy, inflammatory disorders, infection).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11796
Kerolos G Abd-El Malak, MBBCH, 00201276145151, Kerols.ghobreal@deraya.edu.eg
Soheir S Rizkallah, MD
About this study
Official title: Mandibular Splint Versus Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
The study aims to compere mandibular splint versus botox injection in lateral pterygoid on cervical muscle activity in patients with temporomandibular disorders
Read the detailed description
Temporomandibular disorders (TMD) are common chronic musculoskeletal pain conditions among orofacial pain, consisting of a group of conditions associated with pain and dysfunction of the temporomandibular joint (TMJ) and masticatory muscles. Temporomandibular joint displacement, also known as internal disc derangement, is an abnormal relationship between the articular disc, the mandibular condyle, and the mandibular fossa. The most frequent displacement of the disc is anterior to the mandibular condyle however, in rare cases it can be posteriorly.
Occlusal splint treatment is generally considered to be a basic treatment for Temporomandibular disorders. It could promote correction of the vertical dimension, maxillo-mandibular realignment, temporomandibular joint repositioning and cognitive awareness. Although various splints are currently available, the most used are stabilization splints and anterior repositioning splints.
Injection of BTX-A in LP muscle, considering the different methods, frequencies and injection dosages used in different studies, would decrease the clicks and other TMJ-related disorders such as pain, hyperactivity, and dysfunction. Based on the present review, most studies about the injection of botulinum toxin in LP muscle reported cases or were done as quasi-experimental studies.
- Conditions
- Mandibular Splint, Botox, Lateral Pterygoid, Cervical Muscle Activity, Temporomandibular Disorders
- Being tested
- Botox injection, Mandibular stabilization splint, Muscle relaxant
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox injectionDrug
Patients will be treated by Botox injection in lateral pterygoid muscle and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.
A Botox-A vial was diluted with normal saline to a concentration of 10 U per 0.1 mL for injection in a 1-ml insulin syringe. This will be injected into the ipsilateral lateral pterygoid muscle.
Mandibular stabilization splintDrug
Patients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.
Muscle relaxantDrug
Patients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.
| Study group | Role | What they receive |
|---|---|---|
| Botox injection group | Experimental | Patients will be treated by Botox injection in lateral pterygoid muscle and medications like muscle relaxants, antidepressants, and nonsteroidal anti-inflammatory drugs.
A Botox-A vial was diluted with normal saline to a concentration of 10 U per 0.1 mL for injection in a 1-ml insulin syringe. This will be injected into the ipsilateral lateral pterygoid muscle Receives: Drug: Botox injection |
| Mandibular stabilization splint group | Experimental | Patients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs. Receives: Drug: Mandibular stabilization splint |
| Control group | Active comparator | Patients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs. Receives: Drug: Muscle relaxant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity of upper trapizieus and sternocleidomastoid
Muscle activity of upper trapizieus and sternocleidomastoid will be recorded before and after injection for 3 months by neurosoft Electromyography
Measured: After injection for 3 months.
Secondary outcomes (2)
Amplitude of muscle activity
Amplitude of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography.
Measured: After injection for 3 months.
Root mean square of muscle activity
Root mean square of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography.
Measured: After injection for 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start14 Aug 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular SplintStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolos Ghobrial Goda Abd-El Malak, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553950
- Sponsor's protocol ID
- P.T.REC/012/004426
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Splint Versus Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT06553950
- Acronym / sponsor ID
- P.T.REC/012/004426
- Conditions
- Mandibular Splint, Botox, Lateral Pterygoid, Cervical Muscle Activity, Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 14 Aug 2024 (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 study aims to compere mandibular splint versus botox injection in lateral pterygoid on cervical muscle activity in patients with temporomandibular disorders
Detailed description
Temporomandibular disorders (TMD) are common chronic musculoskeletal pain conditions among orofacial pain, consisting of a group of conditions associated with pain and dysfunction of the temporomandibular joint (TMJ) and masticatory muscles. Temporomandibular joint displacement, also known as internal disc derangement, is an abnormal relationship between the articular disc, the mandibular condyle, and the mandibular fossa. The most frequent displacement of the disc is anterior to the mandibular condyle however, in rare cases it can be posteriorly.
Occlusal splint treatment is generally considered to be a basic treatment for Temporomandibular disorders. It could promote correction of the vertical dimension, maxillo-mandibular realignment, temporomandibular joint repositioning and cognitive awareness. Although various splints are currently available, the most used are stabilization splints and anterior repositioning splints.
Injection of BTX-A in LP muscle, considering the different methods, frequencies and injection dosages used in different studies, would decrease the clicks and other TMJ-related disorders such as pain, hyperactivity, and dysfunction. Based on the present review, most studies about the injection of botulinum toxin in LP muscle reported cases or were done as quasi-experimental studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botox injection group | Experimental | Drug: Botox injectionPatients will be treated by Botox injection in lateral pterygoid muscle and medications like muscle relaxants, antidepressants, and nonsteroidal anti-inflammatory drugs. A Botox-A vial was diluted with normal saline to a concentration of 10 U per 0.1 mL for injection in a 1-ml insulin syringe. This will be injected into the ipsilateral lateral pterygoid muscle |
| Mandibular stabilization splint group | Experimental | Drug: Mandibular stabilization splintPatients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs. |
| Control group | Active comparator | Drug: Muscle relaxantPatients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age from 18-40 years old.
- Both sexes.
- Duration of the disease is more than 3 months.
- Anterior mandibular disc displacement with reduction will be included.
- Unilateral anterior mandibular displacement with reduction grade 2\&3 (Wilkes) will be included.
Key exclusion criteria (12 listed)
- Neurological or musculoskeletal diseases that affect cervical spine other than mandibular disc displacement (eg: cervical spondylosis, spondylolisthesis, and cervical disc injuries)
- Bilateral anterior mandibular disc displacement patients.
- Musculoskeletal disorders such as severe arthritis, cervical spine surgery or contractures of fixed deformity, leg length discrepancy.
- women during pregnancy and lactation.
- Patients with known hypersensitivity to any component of the drug (especially hypersensitivity to human albumin).
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 |
|---|---|---|
| Botox injectionPatients will be treated by Botox injection in lateral pterygoid muscle and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs. A Botox-A vial was diluted with normal saline to a concentration of 10 U per 0.1 mL for injection in a 1-ml insulin syringe. This will be injected into the ipsilateral lateral pterygoid muscle. | Drug | Botox injection group |
| Mandibular stabilization splintPatients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs. | Drug | Mandibular stabilization splint group |
| Muscle relaxantPatients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs. | Drug | Control group |
Primary outcome
Muscle activity of upper trapizieus and sternocleidomastoid
Time frame: After injection for 3 months.
Muscle activity of upper trapizieus and sternocleidomastoid will be recorded before and after injection for 3 months by neurosoft Electromyography
2 secondary outcomes
Amplitude of muscle activity
Time frame: After injection for 3 months.
Root mean square of muscle activity
Time frame: After injection for 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox injection, Mandibular stabilization splint and Muscle relaxant in people with Mandibular Splint and Botox, run by Cairo 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerolos G Abd-El Malak, MBBCH (00201276145151, Kerols.ghobreal@deraya.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activity of upper trapizieus and sternocleidomastoid (time frame: After injection for 3 months.). 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 16 Aug 2024.