The Effects of an Exercise Regimen Following TMJ Arthrocentesis

Completed

• Conditions: Temporomandibular Joint Disorders

• Registration Number: NCT06756412
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

The goal of this study is to evaluate the short- and long-term effects of a self-administered exercise program on pain levels, jaw movement range, and jaw function in patients with temporomandibular joint (TMJ) disorders. The main question it aims to answer is:

Does adding a self-administered exercise program to arthrocentesis improve pain, mouth opening, and jaw function compared to arthrocentesis alone in patients with TMJ disorders?

Participants with acute or chronic TMJ pain lasting at least three months and limited mouth opening will undergo arthrocentesis, with one group also following an exercise regimen. Outcomes will be assessed over a 6-month follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Primary Completion: 2024-01-15
• Study Completion: 2024-07-16
• Status Verified: 2024-12
• Study First Submitted: 2024-12-25
• Study First Submitted QC: 2024-12-25
• Last Update Submitted: 2024-12-25
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Limited mouth opening (<35mm) and joint pain complaints according to the DC/TMD examination form,
• Pain complaints for 3 months or longer,
• Able to understand Turkish in spoken and written language,
• Patients who can read the written consent form and give signed consent will be included in the study.

Exclusion Criteria

• Those with serious neurological disorders,
• Those with autoimmune disorders involving muscles or joints,
• Those with a history of alcoholism,
• Patients diagnosed with malignancy,
• Patients who have previously undergone surgery or radiotherapy in the head and neck region,
• Those with other TMD diagnoses that do not cause restriction or pain in mouth opening,
• Those who have received other treatments for the neck or TMJ regions in the last 3 months,
• Those with a history of surgical treatment for the temporomandibular joint,
• Those with a history of allergy to any of the agents used in the treatment process,
• Those who use drugs that affect the musculoskeletal system, and
• Pregnant patients will not be included in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum Amount of Mouth Opening	Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.	For mouth opening measurement, the distance between the incisal edges of the lower and upper first incisors will be measured using a digital caliper and will be recorded in millimeters at the end of each examination. In patients with missing teeth, the teeth on the left side will be used for the measurement. In order to determine the amount of movement of the lower jaw in the lateral direction, patients will be asked to shift their lower jaws to the right and left. The amount of displacement of the midline of the lower jaw teeth relative to the midline of the upper jaw teeth will be measured with a digital caliper. The distances obtained will be recorded in millimeters at the end of each examination.
Pain Intensity	Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.	A visual analog scale (VAS) will be used to measure pain intensity. The scale consists of a 10-centimeter straight line, with '0' at the starting point indicating no pain and '10' at the endpoint representing the highest pain level tolerable. During each examination session, individuals will mark the point on the line that corresponds to their pain intensity. The distance from the '0' point to the marked position will be measured in centimeters, with greater distances indicating higher pain intensity.

Secondary Outcome Measures

Name	Time	Method
Jaw Function Limitation	Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.	The Jaw Function Limitation Scale (JFLS-20) will be administered to patients during all examination sessions using a standardized form. This scale assesses the extent to which daily activities are restricted by TMD symptoms. It includes 20 jaw functions, each scored by the patient on a scale from 0 to 10, where '0' indicates no impact and '10' indicates extreme difficulty performing the function due to TMD. The individual scores are summed to calculate a total score, with higher scores indicating greater limitations in jaw function.

Trial Locations

Locations (1)

Uşak University, Faculty of Dentistry; 🇹🇷 Uşak, Turkey