CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Physical therapy +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04819763
NCT04819763N/ACompleted

Training of the Lateral Pterygoid Muscle in the Treatment of Anterior Temporomandibular Joint Disc Displacement With Reduction With Pain

University Medicine Greifswald·interventional·Posted Mar 29, 2021·Updated Dec 8, 2023

In Brief

A clinical study evaluating Physical therapy and Appliance therapy for Facial Pain and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 29, 2021
Enrollment StartMay 3, 2021
Primary CompletionNov 7, 2022
Study CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.3 years ago

Interventions

Physical therapyother

Coordination training for lateral movement of the mandible (spatula exercise): 1. A wooden spatula is loosely placed between the teeth of the upper and lower jaw; the head must be aligned with the body axis; the exercise should be performed in front of a mirror. 2. The lower jaw moves to the left and back to the center with little contact to the spatula 3. The lower jaw moves to the right and back to the center under contact with the spatula Training of the left lateral pterygoid muscle: 1. The left palm is placed on the left temple region 2. Right hand forms a fist and is placed on the tip of the right chin 3. Both arms are aligned parallel to the surface of the floor 4. The lower jaw is moved to the right against a moderate resistance of the fist = concentric muscle work 5. With measured force of the fist, the lower jaw is brought back to the center = eccentric muscle work (Right lateral pterygoid muscle training with opposite hands.)

Appliance therapyother

Upper and lower jaw impressions are registered by using an intraoral scanner. The arbitrary hinge axis position is determined using a face bow. The stabilization appliance with anterior canine guidance is manufactured in the Lexmann laboratory in Dresden. The stabilization appliance is incorporated by the dentist and the static and dynamic occlusion is checked. A tension-free fit of the appliance on the lower jaw is necessary. Additionally, equal contacts in the side teeth area and incisors guidance in the case of mandibular protrusion are checked visually and by using occlusion foil. During mandibular lateral movement only the canine guidance takes place and is also registered optically and by using occlusion foil.Interference contacts should be adjusted. The patient is instructed to wear the stabilization appliance while sleeping. The wearing rhythm is described as intermittent. (three nights - wearing the appliance, one night - not wearing the appliance).