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

NCT ID: NCT07016256

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-30

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.

Conditions

Muscular TMD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lucia jig

Lucia jig splint

Group Type: EXPERIMENTAL

intraoral devices

Intervention Type: DEVICE

Intraoral devices not registed with a patent

Sved splint

Sved splint

Group Type: EXPERIMENTAL

intraoral devices

Intervention Type: DEVICE

Intraoral devices not registed with a patent

Occlusal splint

Occlusal splint

Group Type: EXPERIMENTAL

intraoral devices

Intervention Type: DEVICE

Intraoral devices not registed with a patent

Interventions

intraoral devices

Intraoral devices not registed with a patent

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Vina del Mar

OTHER

Sponsor Role: lead

Responsible Party

Nicolás Pinto Pardo

Nicolas Pinto-Pardo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Viña del Mar

Viña del Mar, Región de Valparaíso, Chile

Countries

Chile

Other Identifiers

UVMODO012025

Identifier Type: -

Identifier Source: org_study_id