Effect of Intra-articular Injection on Temporomandibular Joint Dysfunction

NCT06213675 | Withdrawn DMC

• 1 other identifier: 2024-KY-0107-011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Temporomandibular Joint Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

the experimental group

EXPERIMENTAL

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.

Behavioral: Routine rehabilitation treatment; Procedure: Intra-articular Injection

The control group

ACTIVE COMPARATOR

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

Behavioral: Routine rehabilitation treatment

Interventions

Routine rehabilitation treatment BEHAVIORAL

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 control group; the experimental group

Intra-articular Injection PROCEDURE

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.

the experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zheng Da yi Yuan Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: January 15, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 15, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)