MOD-SPPersonalized Occlusal Splints Using MODJAW Kinematic Data for Bruxism and TMJ Disorders
MODJAW-Based Patient-Specific Occlusal Splint
+ Standard Occlusal Splint
Behavior+2
+ Bruxism
+ Habits
Treatment Study
Summary
Study start date: October 15, 2025
Actual date on which the first participant was enrolled.This study focuses on bruxism and temporomandibular joint (TMJ) disorders, conditions that can cause jaw pain, headaches, tooth wear, and reduced quality of life. Occlusal splints, devices that stabilize the jaw and distribute biting forces, are commonly used to manage these conditions. However, standard splints do not account for individual jaw movement patterns. This study aims to evaluate if patient-specific occlusal splints, designed using MODJAW kinematic data for individual jaw movements, provide better clinical outcomes compared to standard splints. The study could potentially improve comfort, jaw function, and clinical outcomes for those suffering from bruxism or TMJ disorders. The study is a prospective, randomized, controlled interventional study involving 40 participants with mild-to-moderate bruxism or TMJ dysfunction. Participants will be divided into two groups. The MODJAW group will receive a patient-specific occlusal splint designed using 3D mandibular kinematic data collected with MODJAW. The standard splint group will receive a conventional occlusal splint. Over 8 weeks, participants will wear their assigned splints and attend follow-up assessments. The study's primary outcome is to measure changes in mandibular movement patterns using MODJAW. Secondary outcomes include reduction in TMJ pain, patient-reported satisfaction and comfort, and any adverse events related to splint use.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Age 18-50 years * Diagnosed with mild-to-moderate bruxism or temporomandibular joint (TMJ) dysfunction * Willingness and ability to comply with splint use and study visits * Signed informed consent Exclusion Criteria: * Severe dental loss or existing prosthetic devices interfering with splint placement * Systemic medical conditions affecting jaw function * History of TMJ trauma or surgery * Pregnancy or breastfeeding * Allergy to splint materials
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location