Occlusal Splint and Exercise Therapy for Temporomandibular Disorders

ConditionTemporomandibular Disorders (TMD)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAcibadem University

About this trial

The goal of this clinical trial is to learn if an exercise protocol can improve temporomandibular pain, jaw function and muscle mechanical properties in individuals with Temporomandibular Disorders (TMD). This study focuses on patients who are already receiving occlusal splint therapy.

The main question it aims to answer is:

How does the addition of an exercise protocol to occlusal splint therapy affect temporomandibular pain, jaw function and muscle mechanical properties of the masticatory and neck muscles? Researchers will compare the group receiving both occlusal splint therapy and the exercise protocol to a group only occlusal splint therapy to see if the combined approach is more effective.

Participants will:

* Undergo an initial assessment of the Jaw Functional Limitation Scale-20 (JLFS-20), Craniofacial Pain and Disability Inventory (CF-PDI), Graded Chronic Pain Scale Version 2.0 (GCPS-2.0), jaw range of motion, pain pressure threshold and muscle mechanical properties. * Receive occlusal splint therapy as a part of their treatment. * Perform a structured exercise protocol (only 1 group) * Attend follow up sessions at the 4th week to monitor changes in all initial assessment parameters.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical and radiological diagnosis of TMD

Being between 18-65 years of age

Presence of Temporomandibular Joint (TMJ) pain for the last 3 months.

Disqualifiers

Intra-articular or degenerative joint disorders and subluxation requiring immediate treatment,

A history of TMJ or cervical region surgery in the last 3 months,

A history of treatment from related regions,

The presence of rheumatic diseases, including TMJ diseases,

Trial design

Design model

Parallel

Treatments tested in this trial

Occlusal Splint
Device
Participants will be provided with custom-made hard acrylic occlusal splints. They will be instructed to wear the appliance every night during sleep for a period of four consecutive weeks. A licensed dentist will manage the delivery and occlusal adjustment of the splints to ensure they were correctly seated and well-tolerated by the subjects. Both groups will receive a occlusal splint to be worn every night.
Exercise
Behavioral
Participants will perform the Rocabado 6x6 exercise protocol, which consists of six specific movements designed to restore proper tongue position, improve jaw mobility, and stabilize the craniomandibular relationship. Each exercise will be performed 6 times per session, 6 times a day. The protocol includes: Rest position of the tongue, shoulder posture, stabilized head flexion, axial extension of the neck, control of TMJ rotation and rhythmic stabilization technique. The program consists of performing 6 specific exercises, 6 times per day with 6 repetitions each, for 4 weeks.

Treatment groups

38 Participants

are divided into 2 treatment groups

Group A: Splint Group (S Group)Active comparator 1 intervention

Group B: Exercise and Splint Group (ES Group)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Jaw Range of Motion

Pain-free opening, maximum unassisted opening, maximum assisted opening, lateral and protrusive movements will be mesured by a ruler. All measurements will be noted in milimeters between the incisal edges of upper and lower central incisors. The average of the 3 repetitions will be taken.

Time frame