Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
Study NCT ID:
NCT06553950
Status:
RECRUITING
Last Update Posted:
2024-08-16
First Post:
2024-08-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle activity of upper trapizieus and sternocleidomastoid', 'timeFrame': 'After injection for 3 months.', 'description': 'Muscle activity of upper trapizieus and sternocleidomastoid will be recorded before and after injection for 3 months by neurosoft Electromyography'}], 'secondaryOutcomes': [{'measure': 'Amplitude of muscle activity', 'timeFrame': 'After injection for 3 months.', 'description': 'Amplitude of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography.'}, {'measure': 'Root mean square of muscle activity', 'timeFrame': 'After injection for 3 months.', 'description': 'Root mean square of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mandibular Splint', 'Botox', 'Lateral Pterygoid', 'Cervical Muscle Activity', 'Temporomandibular Disorders']}, 'descriptionModule': {'briefSummary': 'The study aims to compere mandibular splint versus botox injection in lateral pterygoid on cervical muscle activity in patients with temporomandibular disorders', 'detailedDescription': '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.\n\nOcclusal 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.\n\nInjection 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18-40 years old.\n* Both sexes.\n* Duration of the disease is more than 3 months.\n* Anterior mandibular disc displacement with reduction will be included.\n* Unilateral anterior mandibular displacement with reduction grade 2\\&3 (Wilkes) will be included.\n* Patients with cervical muscles spasm and trigger points (upper trapezius\\& sternocleidomastoid) will be included.\n* Patients with sufficient cognitive abilities that enables them to understand and follow instructions.\n\nExclusion Criteria:\n\n* Neurological or musculoskeletal diseases that affect cervical spine other than mandibular disc displacement (eg: cervical spondylosis, spondylolisthesis, and cervical disc injuries)\n* Bilateral anterior mandibular disc displacement patients.\n* Musculoskeletal disorders such as severe arthritis, cervical spine surgery or contractures of fixed deformity, leg length discrepancy.\n* women during pregnancy and lactation.\n* Patients with known hypersensitivity to any component of the drug (especially hypersensitivity to human albumin).\n* 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).\n* Patients being treated with aminoglycoside antibiotics, ciclosporin, D-penicillamine, tubocurarine, pancuronium, gallamine, succinylcholine, chloroquine, or hydroxychloroquine.\n* History of cervical spine surgery.\n* History of trauma or fractures in cervical spine.\n* Signs of cervical radiculopathy or myelopathy.\n* Vascular syndrome such as vertebrobasilar insufficiency.\n* Signs of serious pathology ( e.g., malignancy, inflammatory disorders, infection).'}, 'identificationModule': {'nctId': 'NCT06553950', 'briefTitle': 'Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Mandibular Splint Versus Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botox injection group', 'description': 'Patients will be treated by Botox injection in lateral pterygoid muscle and medications like muscle relaxants, antidepressants, and nonsteroidal anti-inflammatory drugs.\n\nA 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', 'interventionNames': ['Drug: Botox injection']}, {'type': 'EXPERIMENTAL', 'label': 'Mandibular stabilization splint group', 'description': 'Patients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.', 'interventionNames': ['Drug: Mandibular stabilization splint']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.', 'interventionNames': ['Drug: Muscle relaxant']}], 'interventions': [{'name': 'Botox injection', 'type': 'DRUG', 'description': 'Patients will be treated by Botox injection in lateral pterygoid muscle and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.\n\nA 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.', 'armGroupLabels': ['Botox injection group']}, {'name': 'Mandibular stabilization splint', 'type': 'DRUG', 'description': 'Patients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.', 'armGroupLabels': ['Mandibular stabilization splint group']}, {'name': 'Muscle relaxant', 'type': 'DRUG', 'description': 'Patients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Kerolos G Abd-El Malak, MBBCH', 'role': 'CONTACT', 'email': 'Kerols.ghobreal@deraya.edu.eg', 'phone': '00201276145151'}, {'name': 'Soheir S Rizkallah, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aya A Khalil, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Kerolos G Abd-El Malak, MBBCH', 'role': 'CONTACT', 'email': 'Kerols.ghobreal@deraya.edu.eg', 'phone': '00201276145151'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Physical Therapy , Faculty of Physical Therapy ,Cairo University, Cairo, Egypt.', 'investigatorFullName': 'Kerolos Ghobrial Goda Abd-El Malak', 'investigatorAffiliation': 'Cairo University'}}}}