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Clinical trial

Intra-articular Injection Versus Normal Rehabilitation Therapy on Temporomandibular Joint Dysfunction: A Randomized Controlled Study

ID
Name
Intra-articular Injection
Description
The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction The main question it aims to answer is: • Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Not yet recruiting
Treatment
Routine rehabilitation treatment
Routine rehabilitation treatment Includes oral rehabilitation, rehabilitation training for temporomandibular disorders, orthodontic treatment, and other physical therapy methods.which can alleviate symptoms by adjusting the bite, relaxing muscles, and increasing the range of motion of the temporomandibular joint. Besides, it also Includes temporomandibular joint exercise training, relaxation training for facial muscles, and functional chewing training aimed at improving temporomandibular joint function and muscle balance.
Arms:
Routine rehabilitation treatment, Routine rehabilitation treatment+Intra-articular Injection
Intra-articular Injection
The patient is positioned to maximize mouth opening, and a needle is inserted approximately 10-12 mm in front of the tragus after touching the ankle prominence. An 8# injection needle is chosen and inserted upward and slightly forward into the joint cavity. A total of 2 mL of lidocaine hydrochloride injection solution is injected, repeated once every 5 days for a total of 15 days.
Arms:
Routine rehabilitation treatment+Intra-articular Injection
Lidocaine Hydrochloride
The patient is positioned to maximize mouth opening, and a needle is inserted approximately 10-12 mm in front of the tragus after touching the ankle prominence. An 8# injection needle is chosen and inserted upward and slightly forward into the joint cavity. A total of 2 mL of lidocaine hydrochloride injection solution is injected, repeated once every 5 days for a total of 15 days.
Arms:
Routine rehabilitation treatment+Intra-articular Injection
Size
80
Primary endpoint
Friction Index
day 1 and day 15
Eligibility criteria
Inclusion Criteria: * Presence of significant temporomandibular disorder clinical symptoms. * Meeting the diagnostic criteria for Temporomandibular Joint Dysfunction and confirmed by X-ray examination. * Patients voluntarily participate in this study and provide signed informed consent. * Normal cognitive function Exclusion Criteria: * Rheumatic, rheumatoid, or other severe systemic diseases. * Infectious temporomandibular joint arthritis or joint tumors. * Individuals who have recently received joint injection treatment or photodynamic therapy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-03-25

1 organization

1 product

1 indication

Organization
Copka Sonpashan
Product
Lidocaine
Indication
Temporomandibular Joint Dysfunction