Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters

Yuzuncu Yıl University

Status

Completed

Conditions

Occlusion

Quality of Life

Treatments

Drug: Thiocolchicoside

Drug: Etodolac 400 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT05261971

21.11.2018/01

Details and patient eligibility

About

The temporomandibular joint (TMJ) is closely related to neuromuscular components. A problem occurring in any of these components or parts of the TMJ interferes with the harmonic functioning of the TMJ and invites temporomandibular joint disorders (TMD).Management of TMD can be conservative or surgical. Physiotherapy, local steam application, external muscle massage, occlusal adjustment, analgesic and physiotherapeutic medication and splint treatments are the most frequently recommended conservative treatments. Today, occlusal adjustments are made with the help of a prosthetic or orthodontic appliance. With these intraorally used occlusal splints, a balanced occlusal contact is achieved without applying any force to the mandible in the resting position. Occlusal splints are available in different designs and different construction materials. The stabilization splint, which is one of the most frequently used occlusal splints, and the modified Hawley splint are appliances produced from hard materials. However, some researchers have commented that soft splints produced from resilient materials may also be useful in the distribution of excessive force formed in parafunctional habits. While there are studies stating that hard splints provide more successful results than soft splints in functional problems of the chewing system, there are also studies reporting that they have similar efficacy on muscle pain after short-term use. However, there are no studies in the literature that compare their efficacy in short-term and long-term myalgia patients and demonstrate their efficacy using an objective test such as digital occlusion analysis. There was no study on the effectiveness of different splints on the patient's quality of life. It would be appropriate to carry out our study to fill this gap in the literature.The main purpose of this study is to digitally examine and compare the effects of three different treatment methods (medical therapy, medical therapy+soft splint, medical therapy +hard splint) applied to patients diagnosed with facial myalgia after temporomandibular joint examination on the existing occlusion changes.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

No systemic disease that may have effects on masticatory muscles or TMJ
Individuals who do not have any tooth loss other than molar teeth and accept the treatments to be performed.

Exclusion criteria

Individuals with total or partial prosthesis with distal extension
Individuals who have previously received medical, pharmacological or any type of treatment for TMD
Individuals who have recently been exposed to facial or cervical trauma
Individuals with the syndrome who have the potential to affect any component of the stomatognathic system
Individuals with parafunctional habits such as clenching or grinding their teeth.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Medical therapy

No Intervention group

Description:

One non-steroidal anti-inflammatory drug (400mg etodolac) and one muscle relaxant drug (4 mg thiocolchicoside) were prescribed to the patients in this group.

Hard Splint Therapy

Active Comparator group

Description:

The patients in this group were asked to use a hard splint delivered to them to use at night.

Treatment:

Drug: Thiocolchicoside

Drug: Etodolac 400 MG

Soft Splint Therapy

Active Comparator group

Description:

The patients in this group were asked to use a soft splint delivered to them to use at night.

Treatment: