Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)

Evaluation of Resilient Occlusal Splints in the Control of Patients With Temporomandibular Disorder (TMD)

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01150110

Enrollment

Unknown

Registered

2010-06-24

Start date

2007-07-31

Completion date

2008-07-31

Last updated

2010-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorders

Keywords

Temporomandibular disorders, occlusal splints, electromyography, TMD (muscle and joint dysfunction), masseteres e anterior temporalis muscles.

Brief summary

The purpose of this study was to compare the effectiveness of soft occlusal splint therapy on the electromyographic activity of masticatory muscles (ateriors temporalis and masseter) before and after the application of a muscle relaxation splint. Electromyography recordings from the masseter and anterior temporalis muscles were analyzed quantitatively during maximal clench, rest and mastication usual, before and after the treatment without a splint. Ten patients whose chief complaint was Temporomandibular Disorders (TMD) were selected for the study. After the initial evaluations soft occlusal splints (muscle relaxation splints) were applied, and the patients were instructed to use the splints for four weeks. Surface electromyographic recordings were taken from each patient, as clinical evaluations of TMD (Index of Helkimo), both evaluations before the beginning of clinical therapy and after four weeks of wearing splints. The data obtained were analyzed by Wilcoxon´s and Friedman´s tests.

Interventions

DEVICEresilient occlusal splints

A resilient occlusal splints (silicone 2mm) was fabricated on the maxillary arch, using a vacuum pressing machine. The occlusal splints were adjusted to eliminate the gross interferences and to obtain occlusal stability with maximum posterior bilateral contacts. Patients were instructed to use the occlusal splints for 24 hours during 30 days. The use was interrupted only during meals.

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Inclusion criteria

* Patients with clinical and/or diagnosis of TMD * With complaints of muscle disorders and / or joint pain, pain symptoms * Presence of occlusal interferences * Minimum of 20 functional teeth in the oral cavity with subsequent bilateral occlusion

Exclusion criteria

* Individuals with extensive dental flaws * Orthodontic treatment in progress * History of systemic diseases as advanced arthritis, diabetes and conservative and reversible treatments such as occlusal splints are recommended

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026