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Clinical Trials/NCT06328998
NCT06328998
Not Yet Recruiting
N/A

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

Copka Sonpashan0 sites80 target enrollmentMarch 2024

Overview

Phase
N/A
Intervention
Routine rehabilitation treatment
Conditions
Temporomandibular Joint Dysfunction
Sponsor
Copka Sonpashan
Enrollment
80
Primary Endpoint
Friction Index
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Copka Sonpashan
Responsible Party
Sponsor Investigator
Principal Investigator

Copka Sonpashan

The Research Director

Chao Phya Abhaibhubejhr Hospital

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.

Arms & Interventions

Routine rehabilitation treatment+Intra-articular Injection

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.

Intervention: Routine rehabilitation treatment

Routine rehabilitation treatment+Intra-articular Injection

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.

Intervention: Intra-articular Injection

Routine rehabilitation treatment+Intra-articular Injection

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.

Intervention: Lidocaine Hydrochloride

Routine rehabilitation treatment

The patients receive a 15-day treatment and are required to stay in the hospital during this period. Patients are given routine rehabilitation treatment.

Intervention: Routine rehabilitation treatment

Outcomes

Primary Outcomes

Friction Index

Time Frame: day 1 and day 15

Friction Index is used to assess temporomandibular function. The total scores range from 0 to 57, with higher scores indicating more severe temporomandibular dysfunction.

Secondary Outcomes

  • The Visual Analog Scale(day 1 and day 15)
  • The maximum mouth opening limit(day 1 and day 15)
  • Mann Assessment of Swallowing Ability(day 1 and day 15)

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