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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06301620
Other study ID # GUANJIEQIANG
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date June 2024

Study information

Verified date March 2024
Source Ahmadu Bello University Teaching Hospital
Contact Lavie Ce, Master
Phone 15038177099
Email zenghongjixx@qq.com
Is FDA regulated No
Health authority
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 88
Est. completion date June 2024
Est. primary completion date June 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.

Study Design


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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Muhammad

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
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