Effect of Different Oral Splints on the Maximum Bite Force in TMD Patients

The goal of this clinical trial is to evaluate whether three different types of intraoral splints can increase maximal voluntary mandibular clenching force in adults diagnosed with myogenous temporomandibular disorders (TMD). The main questions it aims to answer are:

Do intraoral splints enhance maximal clenching force in patients with muscle-related TMD? Is there a difference in the effectiveness of the three splint designs in improving muscle strength? Researchers will compare the effects of each splint within the same participants to determine which one most effectively increases clenching force.

Participants will:

Undergo baseline assessment of maximal mandibular clenching force Use each intraoral splint for a 30-day period Complete follow-up assessments after each intervention phase

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Key information

Conditions

Muscular TMD Facial Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Viña del Mar

Viña del Mar, Valparaiso, 2520000, Chile

About this study

This clinical trial aims to evaluate the effect of three different types of intraoral splints on maximal voluntary bite force in patients diagnosed with myogenous temporomandibular disorders (TMD). A total of 150 participants were recruited, consisting of 75 men and 75 women. Each gender group was evenly divided into three intervention arms:

25 participants received the Lucia Jig splint 25 participants received the Sved splint 25 participants received the Occlusal splint All participants were previously diagnosed with muscle-related TMD by a qualified clinician. Each participant served as their own control. Baseline measurements of maximum bite force were recorded prior to the intervention using a gnatodynamometer (Kratos, Brazil). Measurements were taken in two anatomical zones: the incisal zone and the molar zone.

For each zone, three consecutive bite force measurements were recorded, with a 5-minute rest interval between each trial. The average of the three measurements was calculated and used as the baseline value for each zone.

Participants were instructed to use their assigned intraoral splint nightly for a period of 30 days. After this period, they returned for a follow-up assessment. The same measurement protocol was repeated: three bite force recordings in both the incisal and molar zones, each separated by a 5-minute interval. The average of these three post-intervention values was calculated for comparison with the baseline.

This within-subject design allows for the evaluation of changes in bite force attributable to each splint type, and for comparison across the three splint designs. The study seeks to determine whether intraoral splints can enhance muscle strength in patients with myogenous TMD, and which design is most effective in doing so.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with muscular TMD
Not using ant
Non pregnant women.
Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments
Without systemic pathologies.

Exclusion criteria

Treatment for chronic pain, depression, hypertension, convulsion condition with or without medication.
Regular use of benzodiazepines.
Systemic pathologies
Pregnant women

Treatment and study plan

intraoral devices

Device

Intraoral devices not registed with a patent

Primary outcomes

Maximum bite force in the incisal and molar zones

Time frame: From enrollment to 30 days after splint utilization

Each patient will be tested at the beginning of the clinical trial on the maximum bite force in the incisal zone, and after 30 days post splint utilization

Sponsors and collaborators

Lead sponsor

Universidad Vina del Mar

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 11, 2025
Registry last updated: Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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