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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06328998
Enrollment
80
Registered
2024-03-25
Start date
2024-03-31
Completion date
2024-12-31
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Dysfunction

Brief 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

Detailed 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

Interventions

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.

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.

DRUGLidocaine 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.

Sponsors

Copka Sonpashan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Friction Indexday 1 and day 15Friction Index is used to assess temporomandibular function. The total scores range from 0 to 57, with higher scores indicating more severe temporomandibular dysfunction.

Secondary

MeasureTime frameDescription
The Visual Analog Scaleday 1 and day 15The 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.
The maximum mouth opening limitday 1 and day 15The maximum mouth opening limit is measured with precision to 0.1 mm (the distance between the upper and lower lips).
Mann Assessment of Swallowing Abilityday 1 and day 15Mann 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.

Contacts

Primary ContactLavie Ce
linchuangzhuce@163.com15333828388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026