Clinical trial NCT04819763: Physical Exercises for Temporomandibular Disorders
Official title: Training of the Lateral Pterygoid Muscle in the Treatment of Anterior Temporomandibular Joint Disc Displacement With Reduction With Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Pain
Temporomandibular Disorder
Temporomandibular Joint Disorders
Temporomandibular; Functional Disturbance
Keywords: physical therapy
stabilization appliance
clinical trial
dentistry
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized study with control group, stratified by gender.
Primary purpose: TREATMENT

Brief summary: Temporomandibular Disorders are a common clinical picture that appear in particular in people between the age of 20 and 40 years. About 33% of the total population shows symptoms and signs of TMD. Among the temporomandibular joint disorders anterior disc displacement appear to be the most common. In case of limitations of jaw movements and or pain conservative methods including combinations of behavior change, physiotherapy, stabilization appliance therapy and medication are most popular. The benefit of a self-treatment program to strengthen the lateral pterygoid muscle and to learn a properly executed lower jaw sideways movement to achieve pain reduction is up to now not well investigated. The aim of this study is to examine the effectiveness of muscle training for the treatment of patients with anterior disc displacement with reduction (DDWR). 60 patients with DDWR and pain (≥18 years) will be randomly allocated to two groups: 1. Physical exercises, 2. Stabilization appliance therapy. All patients receive a functional examination according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) at baseline.

The training in group 1 includes eccentric and concentric counter-movements of the lower jaw muscle to strengthen and restore a physiological lateral movement of the mandible. The muscle exercises should be performed once a day with 5-6 repetitions per side. The treatment with an equilibration appliance in the lower jaw serves as a comparison group. Patients are instructed to wear the appliance while sleeping. The wearing rhythm is described as intermittent. (three nights - wearing the appliance, one night - not wearing the appliance). The primary target variable is the occurrence of pain in the head and joint area before and during therapy. The variable is measured using a numeric rating scale (NRS; 0-10) during the baseline examination and control check-ups after 2, 4 and 6 months.

Detailed description: The literature describes the cause of a temporomandibular disorder (TMD) as a multifactorial event. It can be influenced by anatomical, neuromuscular, traumatic or psychosocial factors. Disturbances often occur in the condyle-disc complex of the temporomandibular joint. The relationship between the articular disc and the condyle head is pathologically altered. The Diagnostic Criteria for Temporomandibular disorders (DC / TMD) describe the displacement of the disc in 4 different forms: disc displacement with reduction; disc displacement with reduction and intermittent locking; disc displacement without reduction with limited opening and disc displacement without reduction without limited opening. TMDs are a common clinical picture that appears in particular in people between the age of 20 and 40 years. About 33% of the total population show signs and symptoms of TMD.

Studies prove that the displacement of the disc with reduction is the most common disorder among temporomandibular joint disorders. According to the DC / TMD, this clinical picture shows intracapsular and biomechanical alterations. If the mouth is closed, the articular disc is often located in front of the mandibular condyle; if the mouth is opened, the disc moves back to its original position on the condyle. Anterior disc displacement appears to be the most common, although a medial or lateral displacement is also possible. During the disc repositioning clicking, popping or snapping noises are usually recorded. Temporomandibular joint disorders such as disc displacement, can also cause pain. Overstretching of the posterior ligament and a compression of the bilaminar zone mandibular movements can be pain-related. Therefore, clicking, popping or snapping noises in the area of the temporomandibular joint (TMJ) correlate with pain in the surrounding tissue. Those complaints intensify when opening the mouth or chewing food.

The treatment of TMD should be oriented on evidence-based procedures that are easy to implement in practice and have a long-term positive effect on the patient's symptoms. Conservative methods including combinations of behavior change, physiotherapy, splint-therapy and medication are most popular. The physiotherapeutic treatment should pursue different strategies, including manual therapy methods (e.g. mobilization and stretching of the temporomandibular joint and / or the neck area) and the demonstration of exercises in everyday life (e.g. self-mobilization and stretching of the masticatory muscles and / or cervical spine) and in addition educating the patient (e.g. about the perception of parafunctions or relaxation techniques). Conservative attempts for patients with TMD should be the first choice. However, there is still no clear data situation and the data pool of randomized clinical studies on this topic needs to be improved. So far studies demonstrate a positive effect of the tested therapy forms. But the individual studies differ greatly in terms of the patient pool, diagnosis, treatment modalities and the result. Furthermore, a precisely described procedure is missing in some papers. Therefore, an exact reproducibility for practitioners is not executable. More research is needed into the benefits of various non-invasive treatments for TMD.

The primary goal of this study is to decrease the ambiguity in this scientific field. In the past various manual and physiotherapeutic exercise methods have already been tested.

This study is also intended to examine the effectiveness of muscle training for the treatment of patients with anterior disc displacement with reduction. The exercises are primarily supposed to train the lateral pterygoid muscle. The treatment with an equilibration appliance in the lower jaw serves as a comparison group.

Eligibility criteria: Inclusion Criteria:

* Orofacial pain in the joint or muscles, degree NRS≥3
* Clicking phenomenon during TMJ opening or closing movement
* Deviation movement during opening of the lower jaw
* Legal competence and presence of the signed declaration of consent

Exclusion Criteria:

* Drug abuse
* Depression
* Polyarthritis

Primary outcomes:
measure: change orofacial pain: numeric rating scale (NRS; 0-10)
timeFrame: 2 months, 4 months, 6 months
Secondary outcomes:
measure: Change in number of clicking noises
timeFrame: 2 months, 4 months, 6 months
measure: Change in interincisal distance during jaw opening
timeFrame: 2 months, 4 months, 6 months
measure: Change in force degrees for the lateral movement of the mandible (scale 0-5)
timeFrame: 2 months, 4 months, 6 months
Other outcomes:
Locations:
city: Steina
country: Germany
facility: Zahnarztpraxis Dr. Pfanne
Study officials:
affiliation: University Medicine Greifswald
name: Olaf Bernhardt, Prof.
role: PRINCIPAL_INVESTIGATOR
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