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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07016256
Enrollment
150
Registered
2025-06-11
Start date
2024-05-01
Completion date
2025-05-30
Last updated
2025-06-11

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

Conditions

Muscular TMD

Keywords

TMD, oral splints, lucia jig, Sved splint, Occlusal splint, orofacial pain, muscular pain

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.

Interventions

DEVICEintraoral devices

Intraoral devices not registed with a patent

Sponsors

Universidad Vina del Mar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum bite force in the incisal and molar zonesFrom enrollment to 30 days after splint utilizationEach 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

Countries

Chile

Outcome results

None listed

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