Clinical trial NCT06213675: Effect of Intra-articular Injection on Temporomandibular Joint Dysfunction
Official title: A Randomized Controlled Study to Explore the Effect of Intra-articular Injection on Temporomandibular Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Temporomandibular Joint Dysfunction
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Friction Index
timeFrame: day 1 and day 15
Secondary outcomes:
measure: The Visual Analog Scale
timeFrame: day 1 and day 15
measure: The maximum mouth opening limit
timeFrame: day 1 and day 15
measure: Mann Assessment of Swallowing Ability
timeFrame: day 1 and day 15
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng Da yi Yuan Hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References: