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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
The background of Temporomandibular Joint Dysfunction is that it is one of the common diseases in the oral and maxillofacial region, and it is the most common among temporomandibular joint diseases. It is more prevalent in young adults, with the highest prevalence rate at 20-30 years old.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine rehabilitation treatment+Intra-articular Injection | Experimental | The patients receive a 15-day treatment and are required to stay in the hospital during this period. Patients in the experimental group are given routine rehabilitation treatment and intra-articular injections. Lidocaine is used as the injected medication at a dose of 2ml, administered once every 5 days for a total of three injections. |
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| Routine rehabilitation treatment | Active Comparator | The patients receive a 15-day treatment and are required to stay in the hospital during this period. Patients are given routine rehabilitation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine rehabilitation treatment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Friction Index | Friction Index is used to assess temporomandibular function. The total scores range from 0 to 57, with higher scores indicating more severe temporomandibular dysfunction. | day 1 and day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| The Visual Analog Scale | The Visual Analog Scale is used to assess the pain levels of two groups of patients. The total score ranges from 0 to 10, with higher scores indicating more severe pain. | day 1 and day 15 |
| The maximum mouth opening limit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lavie Ce | Contact | 15333828388 | linchuangzhuce@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Nieto Luis | Site Coordinator of United Medical Group | Study Chair |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007270 | Injections, Intra-Articular |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Intra-articular Injection | Procedure | 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. |
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| Lidocaine Hydrochloride | Drug | 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. |
|
The maximum mouth opening limit is measured with precision to 0.1 mm (the distance between the upper and lower lips).
| day 1 and day 15 |
| Mann Assessment of Swallowing Ability | Mann Assessment of Swallowing Ability is used to assess swallowing function. The maximum score on the scale is 200. Each item on the scale is scored from 0 to 6, and the total score is calculated by summing up the scores across all items. A higher score indicates better swallowing ability, while a lower score suggests the presence of swallowing difficulties. | day 1 and day 15 |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |