Clinical trial NCT07016256: Effect of Different Oral Splints on the Maximum Bite Force in TMD Patients
Official title: Effect of Different Oral Splints on the Maximum Bite Force in TMD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular TMD
Keywords: TMD
oral splints
lucia jig
Sved splint
Occlusal splint
orofacial pain
muscular pain
Lead sponsor: Universidad Vina del Mar
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 75 men and 75 women diagnosed with muscular TMD, dividen in 3 groups (25 patients each) to evaluate 3 different oral splints on the maximum bite force
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum bite force in the incisal and molar zones
timeFrame: From enrollment to 30 days after splint utilization
Secondary outcomes:
Other outcomes:
Locations:
city: Viña del Mar
country: Chile
facility: Universidad Viña del Mar
state: Valparaiso
Study officials:
References: