Intra-articular Injection Versus Normal Rehabilitation Therapy on Temporomandibular Joint Dysfunction

Temporomandibular Joint Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06328998
• Other study ID #: Intra-articular Injection
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Chao Phya Abhaibhubejhr Hospital
• Contact: Lavie Ce
• Phone: 15333828388
• Email: linchuangzhuce[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Behavioral:
• 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.

Procedure:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Copka Sonpashan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	The maximum mouth opening limit	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
Secondary	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